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

Study Overview
=================
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.

Official Title
-----------------
Evaluating Alternative Delivery Models for Arthritis Self-management Interventions

Conditions
-----------------
Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Behavioral: Phone-Based Walk With Ease


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone-Based Walk With Ease Program<br>Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program | Behavioral: Phone-Based Walk With Ease<br>* 6 week phone-delivered Walk With Ease Program<br>|
| Other: Delayed Phone-Based Walk With Ease Program<br>Telephone-Based Walk With Ease Program starting after the 1 year assessment | Behavioral: Phone-Based Walk With Ease<br>* 6 week phone-delivered Walk With Ease Program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Visual analog scale (100 mm) | Baseline to 6 weeks | 
| Change in pain | Visual analog scale (100 mm) | Baseline to 6 months | 
| Change in pain | Visual analog scale (100 mm) | Baseline to 12 months | 
| Change in physical function - chair stands | repetitions completed during 30 second chair stand test | Baseline to 6 weeks | 
| Change in physical function - chair stands | repetitions completed during 30 second chair stand test | Baseline to 6 months | 
| Change in physical function - chair stands | repetitions completed during 30 second chair stand test | Baseline to 12 months | 
| Change in physical function - 6 minute walk | Distance walked (ft) during 6 minute walk test | Baseline to 6 weeks | 
| Change in physical function - 6 minute walk | Distance walked (ft) during 6 minute walk test | Baseline to 6 months | 
| Change in physical function - 6 minute walk | Distance walked (ft) during 6 minute walk test | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Baseline to 6 weeks | 
| Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Baseline to 6 months | 
| Change in Physical Limitations | Health Assessment Questionnaire (HAQ) - Total score ranging from 0-3, with a higher score indicating more impairment or disability | Baseline to 12 months | 
| Change in physical activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Baseline to 6 weeks | 
| Change in physical activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Baseline to 6 months | 
| Change in physical activity | total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors | Baseline to 12 months | 
| 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 | Baseline to 6 weeks | 
| 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 | Baseline to 6 months | 
| 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 | Baseline to 12 months | 
| Change in blood pressure | Diastolic and systolic blood pressure measured in mmHg | Baseline to 6 weeks | 
| Change in blood pressure | Diastolic and systolic blood pressure measured in mmHg | Baseline to 6 months | 
| Change in blood pressure | Diastolic and systolic blood pressure measured in mmHg | Baseline to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Physical activity, Intervention