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

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluating Alternative Delivery Models for Arthritis Self-management Interventions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05289544
• Other study ID #: Pro00115106
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 29, 2024

Study information

• Verified date: October 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Fibromyalgia
• Gout
• Lupus Erythematosus, Systemic
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• Phone-Based Walk With Ease
6 week phone-delivered Walk With Ease Program

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain	Visual analog scale (100 mm)	Baseline to 6 weeks
Primary	Change in pain	Visual analog scale (100 mm)	Baseline to 6 months
Primary	Change in pain	Visual analog scale (100 mm)	Baseline to 12 months
Primary	Change in physical function - chair stands	repetitions completed during 30 second chair stand test	Baseline to 6 weeks
Primary	Change in physical function - chair stands	repetitions completed during 30 second chair stand test	Baseline to 6 months
Primary	Change in physical function - chair stands	repetitions completed during 30 second chair stand test	Baseline to 12 months
Primary	Change in physical function - 6 minute walk	Distance walked (ft) during 6 minute walk test	Baseline to 6 weeks
Primary	Change in physical function - 6 minute walk	Distance walked (ft) during 6 minute walk test	Baseline to 6 months
Primary	Change in physical function - 6 minute walk	Distance walked (ft) during 6 minute walk test	Baseline to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in physical activity	total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors	Baseline to 6 weeks
Secondary	Change in physical activity	total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors	Baseline to 6 months
Secondary	Change in physical activity	total moderate and vigorous intensity physical activity (>=2020 cpm) measured by Actigraph GT3x Link activity monitors	Baseline to 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in blood pressure	Diastolic and systolic blood pressure measured in mmHg	Baseline to 6 weeks
Secondary	Change in blood pressure	Diastolic and systolic blood pressure measured in mmHg	Baseline to 6 months
Secondary	Change in blood pressure	Diastolic and systolic blood pressure measured in mmHg	Baseline to 12 months

External Links

•   Study Website