A Mobile Intervention Merging Yoga and Self-Management Skills

Chronic Disease Clinical Trial

— MYSkillsMobile  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758312
• Other study ID #: 21-2632
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• MY-Skills Mobile
Yoga and Self-Management Education

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Clemson University, Colorado State University, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Mobile Application Rating Scale	Usability; 20 items; Range 0-25, Higher score indicates better usability	8 Weeks
Secondary	Patient Health Questionaire-8	Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression	8 weeks
Secondary	PROMIS Physical Function	Physical Function; 20 items with 4 additional global items; Range 0-120; Higher scores indicate better function	8 weeks
Secondary	PROMIS Self-Efficacy for Managing Chronic Conditions	Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy	8 weeks
Secondary	PROMIS Companionship, Emotional, Instrumental Support	Social Support; 14 items, Range 0-70; Higher scores indicate better social support	8 weeks