Clinical trial NCT06522906: Mobilizing Hispanics With Knee Osteoarthritis
Official title: Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Hispanic
Exercise
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Temple University
name: University of Melbourne
First posted: 2024-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Educational sessions attended
timeFrame: 3 month follow-up
measure: Adherence with muscle strengthening program
timeFrame: 3 month follow-up
measure: Adherence with physical activity plan
timeFrame: 3 month follow-up
measure: Satisfaction with program
timeFrame: 3 month follow-up
measure: Perceived helpfulness
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Osteoarthritis disease severity
timeFrame: Baseline and 3 month follow-up
measure: Physical activity
timeFrame: Baseline and 3 month follow-up
measure: Physical activity (self-report)
timeFrame: Baseline and 3 month follow-up
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Ernest Vina, MD
role: PRINCIPAL_INVESTIGATOR
References: