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A Mobile Intervention Merging Yoga and Self-Management Skills (MYSkillsMobile)

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ClinicalTrials.gov Identifier: NCT04758312
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Colorado State University
Clemson University
University of Southern California
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
Chronic disease self-management interventions and meditative movement approaches (.e.g., yoga) can independently improve depressive symptoms. However, to our knowledge there are no interventions integrating evidence-based chronic disease management strategies with yoga to maximize physical, psychological or social outcomes, nor are mobile health platforms commonly used to improve the reach of these integrated interventions. Therefore, we developed Merging-Yoga for Self-Management Skills Mobile (MY-Skills Mobile). Our first aim is to adapt the MY-Skills Mobile to tailor the intervention to older adults with multiple chronic conditions (MCC) by convening a panel of patient and care-partner stakeholders. We will convene four patient and care-partner dyads (N=8) to serve as study partners for three longitudinal focus groups to suggest and review MY-Skills Mobile adaptations. We will then conduct a usability study of MY-Skills Mobile with older adults with MCC and their care-partners. We will conduct two waves of rapid-cycle prototyping with 5 dyads in each wave (N=20). Dyads will participate in MY-Skills Mobile modules. We will then use acceptability surveys and use data in each wave to iteratively adapt MY-Skills Mobile to optimize usability and acceptability.

Condition or disease Intervention/treatment Phase
Chronic Disease Behavioral: MY-Skills Mobile Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Mobile Intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) for Older Adults With Multiple Chronic Conditions and Their Care-Partners
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MY-Skills Mobile Intervention
MY-Skills Mobile is an 8-week intervention merging yoga and self-management offered via remote tools including Zoom (video-conferencing software), Canvas (education software), and Qualtrics (survey software) that can be accessed via a computer or tablet. The self-management content is delivered primarily through asynchronous tools that include educational videos and interactive activities for goal setting, action plan, monitoring goals, and problem-solving practice. Yoga is offered synchronously via Zoom two-times per week for 60 minutes (120 minutes per week). The synchronous yoga sessions will be offered at a time that best accommodates participants' schedules. Yoga will become progressively challenging over the eight weeks and will include seated and standing postures.
 Behavioral: MY-Skills Mobile
Yoga and Self-Management Education


Outcome Measures
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Primary Outcome Measures :
  1. User Mobile Application Rating Scale [ Time Frame: 8 Weeks ]
    Usability; 20 items; Range 0-25, Higher score indicates better usability


Secondary Outcome Measures :
  1. Patient Health Questionaire-8 [ Time Frame: 8 weeks ]
    Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression

  2. PROMIS Physical Function [ Time Frame: 8 weeks ]
    Physical Function; 20 items with 4 additional global items; Range 0-120; Higher scores indicate better function

  3. PROMIS Self-Efficacy for Managing Chronic Conditions [ Time Frame: 8 weeks ]
    Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy

  4. PROMIS Companionship, Emotional, Instrumental Support [ Time Frame: 8 weeks ]
    Social Support; 14 items, Range 0-70; Higher scores indicate better social support


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Older Adults with Multiple Chronic Conditions (MCC) and Depressive Symptoms:

  • over the age of 65 at time of recruitment
  • Multiple chronic conditions: Bayliss Disease Burden/Morbidity Assessment by Self-Report diagnosis > 2 and a disease burden score >2 indicating the presence of at least two chronic conditions that limit activities of daily of living.
  • Presence of depressive symptoms will be screened by the Patient Health Questionnaire-2 Scale (PHQ-2), with a score of > 3 indicating at least mild depressive symptoms.
  • Participants must be community dwelling
  • Live in the United States
  • Speak English
  • Participants must be able to provide informed consent and have the ability to stand with or without an assistive device.
  • We will also use the Patient Activity Readiness Questionnaire (PAR-Q) to determine the safety or possible risk of participation.

Care-Partners:

  • Care-partners include any family, friend, or social support that the older adult identifies
  • at least age 18
  • Can provide informed consent
  • Participants must be able to provide informed consent and have the ability to stand with or without an assistive device.
  • We will also use the Patient Activity Readiness Questionnaire (PAR-Q) to determine the safety or possible risk of participation.

Exclusion Criteria for Older Adults with MCC and Care-Partners:

  • Self-reported diagnosis of Alzheimer's disease or dementia
  • Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
  • Consistent yoga >120 minutes a week
  • Completed self-management education in the last year

Participants will not be excluded due to limited technology access. We will provide temporary tablets and mobile hotspot connectivity to interested participants that do not have hardware or internet access.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758312


Contacts
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Contact: Jennifer Portz, PhD, MSW (303) 724-4438 Jennifer.portz@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jennifer D Portz, PhD       Jennifer.portz@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Colorado State University
Clemson University
University of Southern California
Investigators
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Principal Investigator: Jennifer Portz, PhD, MSW University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04758312    
Other Study ID Numbers: 21-2632
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes