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

December 8, 2022 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MY-Skills Mobile Intervention
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
Yoga and Self-Management Education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
User Mobile Application Rating Scale
Time Frame: 8 Weeks
Usability; 20 items; Range 0-25, Higher score indicates better usability
8 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionaire-8
Time Frame: 8 weeks
Depressive Symptoms; 8 items; Range 0-24; Higher score indicates worse depression
8 weeks
PROMIS Physical Function
Time Frame: 8 weeks
Physical Function; 20 items with 4 additional global items; Range 0-120; Higher scores indicate better function
8 weeks
PROMIS Self-Efficacy for Managing Chronic Conditions
Time Frame: 8 weeks
Self-Efficacy; 24 items; Range 0-120; Higher scores indicate better self-efficacy
8 weeks
PROMIS Companionship, Emotional, Instrumental Support
Time Frame: 8 weeks
Social Support; 14 items, Range 0-70; Higher scores indicate better social support
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Southern California
Colorado State University
Clemson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Portz, PhD, MSW, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-2632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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