- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893590
Adapting mHealth Technology to Improve Patient Activation
Adapting mHealth Technology to Improve Patient Activation and Overall Wellness for Persons With Disabilities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63108
- Washington University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older
- had disability for at least one year
- score of less than 10 on the Modified Fatigue Impact Scale 5 question (MFIS-5)
- ability to read and speak English at the 6th grade level
- willing to use their own phone and SMS
Exclusion Criteria:
- evidence of acute condition (e.g. relapse)
- sleep apnea
- inability to answer interview questions or provide consent
- terminal cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fatigue self-management SMS intervention
The participants will receive a 12-week fatigue self-management SMS text intervention using mobile phones to target patient activation levels in people with disabilities.
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Participants will set up an initial goal for the SMS intervention related to fatigue management, and prior to beginning the intervention they will be trained to use the SMS system.
Participants will receive text messages each day, providing tips and techniques to help self-manage fatigue.
Weekly the participants will be asked to provide feedback regarding their fatigue levels and their patient activation will be re-assessed at the halfway point of intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Activation - change in knowledge, skill and confidence for self-management
Time Frame: Baseline and up to 2 weeks post intervention
|
The Patient Activation Measure (PAM-13) assesses four levels of activation: (1) the patient is disengaged and overwhelmed, (2) the patient is becoming aware but still struggling, (3) the patient takes action, and (4) the patient maintains behaviors.
The psychometric properties of the PAM have been assessed in multiple healthcare settings.
Raw PAM scores can be transformed into a continuous (0-100) scale, where higher scores represent higher levels of patient activation.
In order to target self-management strategies, participants will proceed through these levels.
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Baseline and up to 2 weeks post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Short Form 8a
Time Frame: Baseline and up to 2 weeks post intervention
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The Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue and the impact of fatigue. The fatigue short forms are not disease specific and assess fatigue over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "not at all (1)" to "very much (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score. |
Baseline and up to 2 weeks post intervention
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The Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Disturbance Short Form 8a
Time Frame: Baseline and up to 2 weeks post intervention
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The Sleep disturbance instruments assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The sleep disturbance short forms are not disease specific and assess sleep disturbances over the past seven days. PROMIS instruments are scored using item-level calibrations. Each question is answered using a 5-point Likert scale from "very poor (1)" to "very good (5)". Calculate a summed score and then use the applicable PROMIS score conversion table to translate the total raw score into a T-score. The seven domains are scored individually, and the single pain intensity item is reported as its raw score. |
Baseline and up to 2 weeks post intervention
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Multiple Sclerosis
- Spinal Cord Injuries
Other Study ID Numbers
- 202103191
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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