Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 19
- 主要终点
- OMERACT/OARSI responder criteria
研究概览
简要总结
The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.
详细描述
Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels.
Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial.
The main research questions are:
- To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial).
- To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).
- To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews).
Secondary research questions will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Only investigator conduction the analyses will be blinded to group allocation
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People diagnosed with hand osteoarthritis
- •Possessing a smartphone
排除标准
- •cognitive deficits
- •are scheduled for hand surgery within the next 3 months
- •do not talk or understand Norwegian,
- •have uncontrolled serious comorbidities
结局指标
主要结局
OMERACT/OARSI responder criteria
时间窗: Baseline and 3 months follow-up
Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following: High improvement on pain or function: 1. ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR 2. ≥50% improvement + absolute change of ≥0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand) Improvement in at least two of the three following: 1. ≥20% improvement + absolute change of ≥1 in pain (NRS) 2. ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand) 3. ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS)
次要结局
- Disease activity (intervention group)(Monthly in the intervention period (12 weeks))
- Pain intensity (intervention group)(3 times weekly in the intervention period (12 weeks))
- OMERACT/OARSI responder criteria long-term(3 and 6 months follow-up)
- Measure of Activity performance (MAP-Hand)(Baseline, 3 and 6 months follow-up)
- Pain intensity(Baseline, 3 and 6 months follow-up)
- Disease activity(Baseline, 3 and 6 months follow-up)
- Grip strength(Baseline and 3 months follow-up)
- Change in condition(Baseline, 3 and 6 months follow-up)
- Health care utilization(Baseline, 3 and 6 months follow-up)
- Fatigue(Baseline, 3 and 6 months follow-up)
- Adherence to exercise long-term(3 and 6 months follow-up)
- Adherence to informational videos(During the intervention period (3 months))
- Stiffness(Baseline, 3 and 6 months follow-up)
- Stiffness (intervention group)(3 times weekly in the intervention period (12 weeks))
- Measure of Activity performance (MAP-Hand) (intervention group)(Monthly in the intervention period (12 weeks))
- eHealth literacy(Baseline)
- Health-related quality of life(Baseline, 3 and 6 months follow-up)
- Medication use(Baseline, 3 and 6 months follow-up)
- Motivation for hand exercises(Baseline and 3 monhts follow-up)
- Adverse events(3 and 6 months follow-up)
- Sickleave(Baseline, 3 and 6 months follow-up)
- Adherence to exercise(3 times weekly during the intervention period (3 months))
- Quality indicators for hand osteoarthritis treatment(Baseline, 3 and 6 months follow-up)
- Number of painful joints(Baseline)
- Change in condition (intervention group)(Monthly in the intervention group (3 months))
- Patient satisfaction with care(Baseline, 3 and 6 months follow-up)
- Arthritis self-efficacy scale(Baseline)
- System Usability Scale (SUS)(3 month follow-up)
- Adherence to informational videos long-term(3 and 6 months follow-up)
- Demographic variable(Baseline)
研究者
Anne Therese Tveter
Professor
Diakonhjemmet Hospital