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

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MY-Skills Mobile
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MY-Skills Mobile Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

User Mobile Application Rating Scale
Usability; 20 items; Range 0-25, Higher score indicates better usability

Secondary Outcome Measures

Patient Health Questionaire-8
Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression
PROMIS Physical Function
Physical Function; 20 items with 4 additional global items; Range 0-120; Higher scores indicate better function
PROMIS Self-Efficacy for Managing Chronic Conditions
Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy
PROMIS Companionship, Emotional, Instrumental Support
Social Support; 14 items, Range 0-70; Higher scores indicate better social support

Full Information

First Posted
February 11, 2021
Last Updated
December 8, 2022
Sponsor
University of Colorado, Denver
Collaborators
Colorado State University, Clemson University, University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT04758312
Brief Title
A Mobile Intervention Merging Yoga and Self-Management Skills
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Colorado State University, Clemson University, University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MY-Skills Mobile Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MY-Skills Mobile
Intervention Description
Yoga and Self-Management Education
Primary Outcome Measure Information:
Title
User Mobile Application Rating Scale
Description
Usability; 20 items; Range 0-25, Higher score indicates better usability
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionaire-8
Description
Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression
Time Frame
8 weeks
Title
PROMIS Physical Function
Description
Physical Function; 20 items with 4 additional global items; Range 0-120; Higher scores indicate better function
Time Frame
8 weeks
Title
PROMIS Self-Efficacy for Managing Chronic Conditions
Description
Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy
Time Frame
8 weeks
Title
PROMIS Companionship, Emotional, Instrumental Support
Description
Social Support; 14 items, Range 0-70; Higher scores indicate better social support
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Portz, PhD, MSW
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Mobile Intervention Merging Yoga and Self-Management Skills

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