Clinical trial NCT04758312: A Mobile Intervention Merging Yoga and Self-Management Skills
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado State University
name: Clemson University
name: University of Southern California
First posted: 2021-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: User Mobile Application Rating Scale
timeFrame: 8 Weeks
Secondary outcomes:
measure: Patient Health Questionaire-8
timeFrame: 8 weeks
measure: PROMIS Physical Function
timeFrame: 8 weeks
measure: PROMIS Self-Efficacy for Managing Chronic Conditions
timeFrame: 8 weeks
measure: PROMIS Companionship, Emotional, Instrumental Support
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Portz, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: