- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03772639
Shared Decision Making in Hospitalized AECOPD
February 17, 2020 updated by: Marie Carmen Valenza, Universidad de Granada
Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide.
Patients require good communication with the physician to improve control illness.
Shared decision making is a promising opportunity for chronic disease management due to the relative cost, medicine optimization and decreases hospital admissions/re-admissions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost, physician services, and prescription drugs.
Additionally to the disease progression with the reduction in lung function, COPD patients experiment a progressive decline in functional capacity and health-related quality of life (HRQoL) with a significant burden in terms of disability.
Shared Decision Making is defined as an approach where clinicians and patients share the available information to making clinical decisions, and where patients are counseled.
SDM is a way to empower patients when decisions are made about treatment as a determinant factor in patient-centered care.
Decision aids have been proven effective in improving disease knowledge, decision making, and self-care.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion criteria were COPD patients hospitalized due to acute exacerbation
Exclusion Criteria:
- Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The experimental group received a standard medical and pharmacological care in a daily format and shared decision making (SDM).
The general framework of SDM was developed focusing on self-management goals which include education that addresses continuous use of medication, behavioral change, breathing training, learning to interpret changes in the disease and its consequences, and use of medical and community resources.
|
Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors
|
No Intervention: Control Group
The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index.
The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health).
The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression.
For each item, the subject selects one of 3 descriptive health states (from good to poor).
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COPD Knowledge
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q).
COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010).
The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills.
A higher punctuation indicates better results.
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Adherence of inhalers
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
The Test of Adherence to Inhalers (TAI) was used to assess the level of adherence to inhalers in asthma and COPD patients.
The test has two subscores, first to identify non-adherent patients and to measure the non-adherence level, second was designed to guide clinically the treatment non-compliance patients.
Low adherence is considered when scores are less than 45 points in the 10-items subscore.
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Functional capacity
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Functional independence was assessed using the Functional Independence Mease Scale (FIM).
This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items.
The total score range between 18 points (total dependence) to 126 points (Independence completes).
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Physical activity
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays.
PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week.
Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Nutritional status
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Nutritional status was assessed with Mini Nutritional Assessment (MNA).
The MNA has a screening- and assessment part.
The screening part consists of questions about food intake, weight loss, mobility, stress, neuropsychological problems and weight and height will be combined to report BMI in kg/m^2.
When the MNA punctuation is ≥ 24 nutritional status can be considered good.
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Functional capacity associated with breathlessness
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Functional capacity associated with breathlessness was assessed with London Chest Activity of Daily Living Scale (LCADL): The LCADL is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items).
The use of 0 representing 'I wouldn't do any way' and 5 representing that patients require help.
|
Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
December 5, 2018
First Submitted That Met QC Criteria
December 8, 2018
First Posted (Actual)
December 11, 2018
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 17, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- DF0082UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COPD Exacerbation
-
University Medical Center GroningenCompleted
-
Sociedad Española de Neumología y Cirugía TorácicaGlaxoSmithKlineNot yet recruitingCOPD Exacerbation
-
University of Tennessee Graduate School of MedicineMylan Pharmaceuticals IncRecruiting
-
Malcolm KohlerDeep Breath Intelligence (DBI)RecruitingCOPD ExacerbationSwitzerland
-
Universidad Autonoma de MadridCompleted
-
Guy's and St Thomas' NHS Foundation TrustCompleted
-
Hospital Universitario Marqués de ValdecillaGlaxoSmithKlineUnknown
-
Hospital Universitario Marqués de ValdecillaRecruiting
-
Ottawa Hospital Research InstituteCompleted
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)CompletedCOPD ExacerbationUnited States
Clinical Trials on Shared decision making
-
The University of Texas Health Science Center,...TerminatedPregnancy Related | Elective InductionUnited States
-
Shalvata Mental Health CenterUnknownShared Decision Making With PatientsIsrael
-
Umeå UniversityUnknownPsychosis | Participation, Patient | Psychiatric HospitalizationSweden
-
AstraZenecaBrigham Women's HealthCompletedDiabetes Mellitus Type 2United States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | Asthma
-
Yokohama City UniversityCompleted
-
Christiana Care Health ServicesNational Institute of General Medical Sciences (NIGMS); Thomas Jefferson University and other collaboratorsCompleted
-
UMC UtrechtCompletedShared Decision Making Between Patients and GPs in the Treatment of Type 2 Diabetes in Primary Care.Type 2 Diabetes MellitusNetherlands
-
National Heart, Lung, and Blood Institute (NHLBI)Completed
-
SingHealth PolyclinicsSingapore General HospitalCompletedPatient Engagement | Patient PreferenceSingapore