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Completed

NCT Number: NCT04758312

A Mobile Intervention Merging Yoga and Self-Management Skills

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.

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Key information

Conditions

Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MY-Skills Mobile

Behavioral

Yoga and Self-Management Education

Primary outcomes

  1. User Mobile Application Rating Scale

    Time frame: 8 Weeks

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

A Mobile Intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) for Older Adults With Multiple Chronic Conditions and Their Care-Partners

Acronym: MYSkillsMobile

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Dec 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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