Clinical trial NCT05289544: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Gout
Fibromyalgia
Rheumatoid Arthritis
Osteoarthritis
Lupus Erythematosus, Systemic
Keywords: Arthritis
Physical activity
Intervention
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in pain
timeFrame: Baseline to 6 weeks
measure: Change in pain
timeFrame: Baseline to 6 months
measure: Change in pain
timeFrame: Baseline to 12 months
measure: Change in physical function - chair stands
timeFrame: Baseline to 6 weeks
measure: Change in physical function - chair stands
timeFrame: Baseline to 6 months
measure: Change in physical function - chair stands
timeFrame: Baseline to 12 months
measure: Change in physical function - 6 minute walk
timeFrame: Baseline to 6 weeks
measure: Change in physical function - 6 minute walk
timeFrame: Baseline to 6 months
measure: Change in physical function - 6 minute walk
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Change in Physical Limitations
timeFrame: Baseline to 6 weeks
measure: Change in Physical Limitations
timeFrame: Baseline to 6 months
measure: Change in Physical Limitations
timeFrame: Baseline to 12 months
measure: Change in physical activity
timeFrame: Baseline to 6 weeks
measure: Change in physical activity
timeFrame: Baseline to 6 months
measure: Change in physical activity
timeFrame: Baseline to 12 months
measure: Change in arthritis management self-efficacy
timeFrame: Baseline to 6 weeks
measure: Change in arthritis management self-efficacy
timeFrame: Baseline to 6 months
measure: Change in arthritis management self-efficacy
timeFrame: Baseline to 12 months
measure: Change in blood pressure
timeFrame: Baseline to 6 weeks
measure: Change in blood pressure
timeFrame: Baseline to 6 months
measure: Change in blood pressure
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: