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Phone-Based Based Walk With Ease Program for Adults With Arthritis

Primary Purpose

Arthritis, Gout, Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone-Based Walk With Ease
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis focused on measuring Arthritis, Physical activity, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
  • able to read and write in English
  • plan to live in the Columbia, SC region for next year
  • willing to be randomized to either group
  • complete all baseline measure

Exclusion Criteria:

  • contraindications to exercise (besides arthritis)
  • are pregnant, breastfeeding, or planning to become pregnant in the next year
  • have a serious cognitive impairment

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Phone-Based Walk With Ease Program

Delayed Phone-Based Walk With Ease Program

Arm Description

Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program

Telephone-Based Walk With Ease Program starting after the 1 year assessment

Outcomes

Primary Outcome Measures

Change in pain
Visual analog scale (100 mm)
Change in pain
Visual analog scale (100 mm)
Change in pain
Visual analog scale (100 mm)
Change in physical function - chair stands
repetitions completed during 30 second chair stand test
Change in physical function - chair stands
repetitions completed during 30 second chair stand test
Change in physical function - chair stands
repetitions completed during 30 second chair stand test
Change in physical function - 6 minute walk
Distance walked (ft) during 6 minute walk test
Change in physical function - 6 minute walk
Distance walked (ft) during 6 minute walk test
Change in physical function - 6 minute walk
Distance walked (ft) during 6 minute walk test

Secondary Outcome Measures

Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Change in Physical Limitations
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Change in physical activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Change in physical activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Change in physical activity
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Change in arthritis management self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Change in arthritis management self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Change in arthritis management self-efficacy
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Change in blood pressure
Diastolic and systolic blood pressure measured in mmHg
Change in blood pressure
Diastolic and systolic blood pressure measured in mmHg
Change in blood pressure
Diastolic and systolic blood pressure measured in mmHg

Full Information

First Posted
March 11, 2022
Last Updated
October 11, 2023
Sponsor
University of South Carolina
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05289544
Brief Title
Phone-Based Based Walk With Ease Program for Adults With Arthritis
Official Title
Evaluating Alternative Delivery Models for Arthritis Self-management Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Centers for Disease Control and Prevention

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
The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.
Detailed Description
Participants will be randomized to either start the 6-week program immediately or after one year. Our Walk with Ease by Telephone (WWE-T) program is adapted from the original 6-week community-based group walking program developed by the Arthritis Foundation for adults with arthritis. The phone-based program will include 2 phone calls each week with a trained Walk With Ease Leader for 6 weeks. Assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, Lupus Erythematosus, Systemic
Keywords
Arthritis, Physical activity, Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phone-Based Walk With Ease Program
Arm Type
Experimental
Arm Description
Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program
Arm Title
Delayed Phone-Based Walk With Ease Program
Arm Type
Other
Arm Description
Telephone-Based Walk With Ease Program starting after the 1 year assessment
Intervention Type
Behavioral
Intervention Name(s)
Phone-Based Walk With Ease
Intervention Description
6 week phone-delivered Walk With Ease Program
Primary Outcome Measure Information:
Title
Change in pain
Description
Visual analog scale (100 mm)
Time Frame
Baseline to 6 weeks
Title
Change in pain
Description
Visual analog scale (100 mm)
Time Frame
Baseline to 6 months
Title
Change in pain
Description
Visual analog scale (100 mm)
Time Frame
Baseline to 12 months
Title
Change in physical function - chair stands
Description
repetitions completed during 30 second chair stand test
Time Frame
Baseline to 6 weeks
Title
Change in physical function - chair stands
Description
repetitions completed during 30 second chair stand test
Time Frame
Baseline to 6 months
Title
Change in physical function - chair stands
Description
repetitions completed during 30 second chair stand test
Time Frame
Baseline to 12 months
Title
Change in physical function - 6 minute walk
Description
Distance walked (ft) during 6 minute walk test
Time Frame
Baseline to 6 weeks
Title
Change in physical function - 6 minute walk
Description
Distance walked (ft) during 6 minute walk test
Time Frame
Baseline to 6 months
Title
Change in physical function - 6 minute walk
Description
Distance walked (ft) during 6 minute walk test
Time Frame
Baseline to 12 months
Secondary Outcome Measure Information:
Title
Change in Physical Limitations
Description
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Time Frame
Baseline to 6 weeks
Title
Change in Physical Limitations
Description
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Time Frame
Baseline to 6 months
Title
Change in Physical Limitations
Description
Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability
Time Frame
Baseline to 12 months
Title
Change in physical activity
Description
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Time Frame
Baseline to 6 weeks
Title
Change in physical activity
Description
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Time Frame
Baseline to 6 months
Title
Change in physical activity
Description
total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors
Time Frame
Baseline to 12 months
Title
Change in arthritis management self-efficacy
Description
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Time Frame
Baseline to 6 weeks
Title
Change in arthritis management self-efficacy
Description
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Time Frame
Baseline to 6 months
Title
Change in arthritis management self-efficacy
Description
Confidence to manage symptoms of arthritis assessed by the Arthritis Self-Efficacy Scale. Total score 0-10 with higher scores indicating higher levels of self-efficacy for managing arthritis
Time Frame
Baseline to 12 months
Title
Change in blood pressure
Description
Diastolic and systolic blood pressure measured in mmHg
Time Frame
Baseline to 6 weeks
Title
Change in blood pressure
Description
Diastolic and systolic blood pressure measured in mmHg
Time Frame
Baseline to 6 months
Title
Change in blood pressure
Description
Diastolic and systolic blood pressure measured in mmHg
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia able to read and write in English plan to live in the Columbia, SC region for next year willing to be randomized to either group complete all baseline measure Exclusion Criteria: contraindications to exercise (besides arthritis) are pregnant, breastfeeding, or planning to become pregnant in the next year have a serious cognitive impairment
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available within 30 months of the completion of the project.
IPD Sharing Time Frame
Data will be made available within 30 months of the completion of the project.
IPD Sharing Access Criteria
open access
Links:
URL
https://uofscwalkingstudy.com/
Description
Study Website

Learn more about this trial

Phone-Based Based Walk With Ease Program for Adults With Arthritis

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