Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources

Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources

The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease

Detailed Description

Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.

• Study Type: Observational
• Enrollment (Actual): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with advanced Parkinson's disease admitted to movement disorder specialty clinics

Description

Inclusion Criteria:

1. Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
2. Motivated and confident to test Duodopa home titration using TM
3. Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
4. Understood and signed the study informed consent form

Exclusion Criteria:

1. Dementia or cognitive decline with Mini Mental State Examination score less than 24
2. Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
3. Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
4. Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with Parkinson's disease; Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics. Other name for Duodopa is Levodopa Carbidopa Intestinal Gel (LCIG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant	Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Number of Contacts	Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Total Time for Titration	The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.	From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Total Free Time of Participant	Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.	From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events	Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants	Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Consequences	Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Consequences Due to Technical Events	Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence	Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence	Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?	The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?	The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms	CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider	The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact	The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Time Spent for Health Care Utilization Outside the TM Care Chain	The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.	From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: Eva Dahl, MD, AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: September 30, 2013
• First Posted (Estimate): October 8, 2013

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Parkinson's disease; LCIG; levodopa carbidopa intestinal gel
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P14-000