Mobilizing Hispanics With Knee Osteoarthritis

Not Applicable

Recruiting

Interventions: Behavioral: Muscle Strengthening
Behavioral: General Physical Activity
Behavioral: Education

Brief Summary: The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).

Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.

Study participants will fill out a survey before the start of the study and 3 months after.

Detailed Description: Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.

Recruitment & Eligibility

Inclusion Criteria

Hispanic/Latino ethnicity
≥ 50 years of age
Access to a device with internet connection
Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)
Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions

Exclusion Criteria

Unknown or non-Hispanic ethnicity
Condition that prevents ability to provide consent
Illness with a life expectancy <12 months
History of arthroplasty or prosthetic leg
Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)
Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)

Arm && Interventions

Group	Intervention	Description
Intervention	Muscle Strengthening	Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
Intervention	General Physical Activity	Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
Intervention	Education	Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads
Control	Education	Treatment only includes live video educational sessions about OA

Primary Outcome Measures

Name	Time	Method
Educational sessions attended	3 month follow-up	Number of educational sessions attended by patients and partners will be recorded
Adherence with muscle strengthening program	3 month follow-up	Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)".
Perceived helpfulness	3 month follow-up	Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not)
Satisfaction with program	3 month follow-up	Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied")
Adherence with physical activity plan	3 month follow-up	Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop".

Secondary Outcome Measures

Name	Time	Method
Physical activity (self-report)	Baseline and 3 month follow-up	Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity
Physical activity	Baseline and 3 month follow-up	Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day.
Osteoarthritis disease severity	Baseline and 3 month follow-up	Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain \[primary outcome, range 0-20\] and physical function \[0-68\]) will be calculated.

Locations (1): Banner University Medical Center
🇺🇸
Tucson, Arizona, United States