NCT04758312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

February 11, 2021

Last Update Submit

December 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • User Mobile Application Rating Scale

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

    8 Weeks

Secondary Outcomes (4)

  • Patient Health Questionaire-8

    8 weeks

  • PROMIS Physical Function

    8 weeks

  • PROMIS Self-Efficacy for Managing Chronic Conditions

    8 weeks

  • PROMIS Companionship, Emotional, Instrumental Support

    8 weeks

Study Arms (1)

MY-Skills Mobile Intervention

EXPERIMENTAL

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

Interventions

Yoga and Self-Management Education

MY-Skills Mobile Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Portz, PhD, MSW

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 17, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Locations