MYSkillsMobile: A Mobile Intervention Merging Yoga and Self-Management Skills

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04758312
Collaborator
Colorado State University (Other), Clemson University (Other), University of Southern California (Other)
40
1
1
17
2.4

Study Details

Study Description

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
  • Behavioral: MY-Skills Mobile
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. User Mobile Application Rating Scale [8 Weeks]

    Usability; 20 items; Range 0-25, Higher score indicates better usability

Secondary Outcome Measures

  1. Patient Health Questionaire-8 [8 weeks]

    Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression

  2. PROMIS Physical Function [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 [8 weeks]

    Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy

  4. PROMIS Companionship, Emotional, Instrumental Support [8 weeks]

    Social Support; 14 items, Range 0-70; Higher scores indicate better social support

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of Colorado Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • Colorado State University
  • Clemson University
  • University of Southern California

Investigators

  • Principal Investigator: Jennifer Portz, PhD, MSW, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04758312
Other Study ID Numbers:
  • 21-2632
First Posted:
Feb 17, 2021
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022