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Expanding Exercise Programming for Veterans Through Telehealth

Primary Purpose

Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Telehealth Exercise Sessions with text messaging plus booster sessions
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arthritis focused on measuring osteoarthritis, exercise maintenance, telehealth, group exercise, text messaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diagnosis of symptomatic knee or hip OA Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year physically inactive (add definition) Exclusion Criteria: No telephone access hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months recent hospitalization for cardiovascular/cerebrovascular event serious mental health condition or behavioral issues precluding participating in group exercise terminal illness motor neuron diseases severely impaired hearing, vision, or speech non-English speaking current participation in another OA or exercise intervention or lifestyle change study other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study no primary care physician visit in past 12 months pregnant women.

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CORecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Initiation and Maintenance with Text Messaging and Booster Sessions

Exercise Initiation and Maintenance with Text Messaging alone

Arm Description

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.

Outcomes

Primary Outcome Measures

Number of Referrals
The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility.
Number of sessions attended
The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.
Recruitment
The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success.

Secondary Outcome Measures

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes.

Full Information

First Posted
November 17, 2022
Last Updated
April 6, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05666167
Brief Title
Expanding Exercise Programming for Veterans Through Telehealth
Official Title
Expanding Exercise Programming for Veterans Through Telehealth (CDA 22-066)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
osteoarthritis, exercise maintenance, telehealth, group exercise, text messaging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Initiation and Maintenance with Text Messaging and Booster Sessions
Arm Type
Experimental
Arm Description
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.
Arm Title
Exercise Initiation and Maintenance with Text Messaging alone
Arm Type
Active Comparator
Arm Description
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.
Intervention Type
Behavioral
Intervention Name(s)
Group Telehealth Exercise Sessions with text messaging plus booster sessions
Intervention Description
Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.
Primary Outcome Measure Information:
Title
Number of Referrals
Description
The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility.
Time Frame
3 months
Title
Number of sessions attended
Description
The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.
Time Frame
3 months
Title
Recruitment
Description
The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores
Description
Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes.
Time Frame
Baseline, 3 months, 6 months, and 9 months.
Other Pre-specified Outcome Measures:
Title
Change in 30-second chair stand test
Description
Number of times participant can rise from sitting in a chair in 30 seconds. Higher scores indicate higher function.
Time Frame
Baseline, 3 months, 9 months
Title
Change in 2-minute Step Test
Description
The number of steps in place (right knee to midpoint of upper leg = 1 step) in 2 minutes. Higher scores indicate higher function.
Time Frame
baseline, 3 months, 9 months
Title
Change in Arm Curls
Description
The number of curls performed in 30 seconds. Higher scores indicate higher function.
Time Frame
Baseline, 3 months, 9 months
Title
Change in Accelerometry Data
Description
Gathered using an ActiGraph worn on wrist for 7 consecutive days. Specifically step changes in step counts. Larger increases indicate increased physical activity.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Change in Number of Steps assessed by Pedometer
Description
Daily steps recorded by Veteran in AnnieApp text message reply and in daily exercise logs. Larger increases indicate increased physical activity.
Time Frame
Baseline, 3 months, 6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of symptomatic knee or hip OA Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year physically inactive (add definition) Exclusion Criteria: No telephone access hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months recent hospitalization for cardiovascular/cerebrovascular event serious mental health condition or behavioral issues precluding participating in group exercise terminal illness motor neuron diseases severely impaired hearing, vision, or speech non-English speaking current participation in another OA or exercise intervention or lifestyle change study other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study no primary care physician visit in past 12 months pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Abbate, MD
Phone
(303) 399-8020
Ext
3177
Email
Lauren.Abbate@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew T Stephens
Phone
(720) 723-6726
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Abbate, MD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Abbate, MD
Phone
303-399-8020
Ext
3177
Email
Lauren.Abbate@va.gov
First Name & Middle Initial & Last Name & Degree
Andrew T Stephens
Phone
(720) 723-6726
First Name & Middle Initial & Last Name & Degree
Lauren Abbate, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Expanding Exercise Programming for Veterans Through Telehealth

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