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| Name | Class |
|---|---|
| University of Ottawa | OTHER |
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This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program in older females suffering from hand osteoarthritis (HOA) to evaluate the acceptability of this intervention and assess the feasibility of a larger-scale RCT.
It is a single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20 control, 20 experimental). Control participants are given an educational pamphlet and assigned to a waiting list. The knitting program (-8-week duration) has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays. Measures include knitting adherence (implementation outcomes) as well as stiffness, pain, functional status, hand physical activity level, patient's global impression of change, health-related quality of life, self-efficacy, and grip strength (clinical outcomes measured throughout the 8-week program and 4 weeks after the intervention).
Background: Exercise therapy is effective in reducing symptoms and disability associated with hand osteoarthritis (HOA) but has low adherence. An intervention consisting in a meaningful occupation, such as knitting, may improve adherence to treatment. This pilot randomized controlled trial (RCT) studies the adherence and clinical effectiveness of a knitting program in older females suffering from HOA to evaluate the acceptability of this intervention and assess the feasibility of a larger-scale RCT.
Methods: Single-blind, two-arm pilot RCT with a parallel group design with 40 participants (20 control, 20 experimental). Control participants are given an educational pamphlet and assigned to a waiting list. The knitting program (-8-week duration) has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays. Measures included knitting adherence (implementation outcomes) as well as stiffness, pain, functional status, hand physical activity level, patient's global impression of change, health-related quality of life, self-efficacy, and grip strength (clinical outcomes measured throughout the 8-week program and 4 weeks after the intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | Educational pamphlet and knitting program |
|
| control | Other | Educational pamphlet and assigned to a waiting list |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knitting and education (pamphlet) | Other | Pamphlet and knitting program (-8-week duration). The knitting program has two components: bi-weekly 20-minute group knitting sessions and 20-minute home daily knitting on the 5 remaining weekdays. |
| Measure | Description | Time Frame |
|---|---|---|
| Stiffness | 0-100 visual analog scale where 0 = no stiffness, 100 = worst imaginable stiffness | daily for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dropout rates | Assessed through a in-house questionnaire | week 8 |
| Adherence to the knitting program | It was estimated using the logbook and the seniors club attendance sheet, whereby we divided the number of knitting sessions completed (at the club and at home) by the number of knitting sessions prescribed (56 sessions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa | Ottawa | Quebec | Canada |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Single-blind, two-arm pilot RCT with a parallel group design
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The trained independent evaluator conducting the performance evaluations and calculating the scores of the self-reported questionnaires was blinded.
| Education (pamphlet) | Other | Receive only the pamphlet, not the knitting program. |
|
| Baseline, week 4, week 8, and week 12 |
| pain level | 0-100 visual analog scale where 0 = no pain, 100 = worst imaginable pain | Multiple times daily for 12 weeks |
| Functional status | Was assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). It consists in a 15-item scale, with items grouped into three subsections: A) pain intensity, B) stiffness severity, and C) hand functional status/difficulty in activities of daily living. For each item, scores range from 0 (no symptoms) to 4 (severe symptoms) | Baseline, week 4, week 8, and week 12 |
| Hand physical activity | was measured using an adapted version of the 7-Day Physical Activity Readiness (PAR). It is in the form of a calendar in which participants record the duration (minutes per day) and frequency (days per week) of physical activity. | Baseline, week 4, week 8, and week 12 |
| Patient's global impression of change | It was assessed by asking patients if, following the knitting program, their condition was: 1) very much improved; 2) much improved; 3) minimally improved; 4) no change; 5) minimally worse; 6) much worse; 7) very much worse | Baseline, week 4, week 8, and week 12 |
| Health-related Quality of life (QoL) | It was evaluated using the EuroQoL Index (EQ-5D-5L), which covers mobility, self-care, daily activities, Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | Baseline, week 4, week 8, and week 12 |
| Self-efficacy | It was assessed using The Stanford Arthritis Self-Efficacy Scale, consisting in statements which patients rate on a ten-point scale ranging from 1 (very uncertain) to 10 (very certain). | Baseline, week 4, week 8, and week 12 |
| Bilateral hand grip strength | It was measured using a portable JAMAR Hydraulic Hand Dynamometer in the standardized sitting position | Baseline, week 4, week 8, and week 12 |
| D001519 |
| Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |