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| ID | Type | Description | Link |
|---|---|---|---|
| 991639 | Other Grant/Funding Number | Rheumatology Research Foundation |
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| Name | Class |
|---|---|
| Temple University | OTHER |
| University of Melbourne | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads |
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| Control | Active Comparator | Treatment only includes live video educational sessions about OA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Strengthening | Behavioral | Patients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week. |
| Measure | Description | Time Frame |
|---|---|---|
| Educational sessions attended | Number of educational sessions attended by patients and partners will be recorded | 3 month follow-up |
| Adherence with muscle strengthening program | 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)". | 3 month follow-up |
| Adherence with physical activity plan | 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". | 3 month follow-up |
| Satisfaction with program | Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied") | 3 month follow-up |
| Perceived helpfulness | 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) | 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarthritis disease severity | 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. | Baseline and 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jazmin Dagnino | Contact | (520) 621-6823 | jazmindagnino@arizona.edu | |
| Ernest Vina, MD | Contact | (520) 626-1613 | evina@arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ernest Vina, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Tucson | Arizona | 85713 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| General Physical Activity | Behavioral | The general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals. |
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| Education | Behavioral | Administered by a promotora, treatment will include 4 live video educational sessions about OA |
|
| Physical activity |
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. |
| Baseline and 3 month follow-up |
| Physical activity (self-report) | 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 | Baseline and 3 month follow-up |
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |