Feasibility of a Randomized Trial Comparing Exercise-based Rehabilitation With Non-exercise-based Recovery After Total Knee Arthroplasty; DRAW-TKA Hybrid 1 Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Feasibility Trial - Primary outcome is an evaluation of trial feasibility:
研究概览
简要总结
The aim of this feasibility trial is to investigate the feasibility of a trial intervention for a population of patients after total knee replacement for osteoarthritis. This study follows a hybrid type 1 design where the primary focus is on the feasibility of the intervention, and the secondary focus is on gaining a better understanding of context and acceptability.
The main questions it aims to answer are:
- Recruitment (Process/Resources): Are patients willing to engage, and stay, in the trial (estimated by inclusion-rate, participant retention, etc.) and what reasons do patients give for not wishing to enroll or later dropping out of the trial? (inquired face-to-face, during enrolment).
- Harms (Scientific): Does the non-exercise intervention appear "safe" (i.e. not harmful) for the patients? (estimated by for instance: adverse events, reasons for dropouts and sense of security).
- Trial procedure feasibility (Management/Scientific): How well does recruitment and trial procedures work at trial sites? (estimated through feedback from site personnel).
- Participant (patient) experienced acceptability of their assigned intervention: An interview-based follow-up using the Theoretical Framework of Acceptability.
Participants will be randomized to one of two interventions, at discharge from the hospital, following knee replacement, which are being tested for feasibility:
- "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise).
- "Return to everyday life" - no referral to municipal physiotherapy.
Participants in both groups are encouraged to follow WHO guidelines of physical activity, to the degree that their post-surgical symptoms allow (within their orthopedic surgeon's recommendations/limitations). All participants are given a "symptom guide", meaning a folder containing information on what to expect, and when and what to react to, during their recovery after the knee-replacement.
For clarity it should be mentioned, that the quantitative and qualitative data-outputs will be reported separately for improved clarity (the study is not a mixed methods design).
详细描述
Feasibility-criteria (Handling of feasibility outcomes: primary and secondary):
As the feasibility-trial investigates a combination of randomization acceptance, trial procedures, and intervention organization, a primary outcome measure is not specified. The outcome measures planned in the large scale effectiveness trial will be applied, but the outcomes will not be used to assess efficacy, as the trial is not powered for these outcomes. They will be used to indicate efficiency of trial procedures and safety, and to gain information on patients' willingness to enroll and remain in the trial.
Feasibility outcomes will be assessed when all 24 feasibility participants have completed their 12-week follow-up outcome-assessment. An overall assessment of large-scale trial feasibility will be made in the main investigator group, by comparing feasibility research questions with feasibility criteria/outcomes. As there are many components within the feasibility criteria, a summary of findings will be produced. This is used to inform a discussion (main investigator group) to find consensus regarding a final decision on whether a large-scale trial is considered feasible (see Criterion interpretation below).
The feasibility components are organized as related to process, resources, management and scientific, as proposed by Thabane (Thabane et al., 2010). The recruitment (process and resources) is considered the primary feasibility outcome and thusly has specified feasibility criteria.
Criterion interpretation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator and Outcomes Assessor are blinded to participant group allocation. Further, the personnel administering the intervention after discharge from the surgical ward (Care Provider) is masked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Residing in one of fourteen collaboration municipalities
- •Referral to primary total knee arthroplasty for osteoarthritis
排除标准
- •Insufficient danish skills (read/write/speak) to understand questionnaires and outcomes
- •Inability to provide informed consent
- •Severe surgical sequelae (i.e. requiring revision surgery, joint mobilization under anaestesia, or joint infection)
结局指标
主要结局
Feasibility Trial - Primary outcome is an evaluation of trial feasibility:
时间窗: Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
The following criteria are considered most important to evaluate feasibility: * No more than 20% of participants may drop out of the "return-to-everyday-life" group because they change their mind and wish to receive exercise-based rehabilitation instead (wish to cross over) * At least 10% of the patients who receive full trial information, are subsequently enrolled in the trial * At least 85% of enrolled participants complete the primary outcome assessment at 12 weeks * At least one participant (on average) must be included at each site, each week The criteria, and and all other outcomes, form the basis of a trial group discussion with the intent of agreeing on one of the following interpretations (large-scale trial feasibility): 1) Main study not feasible - stop main study, 2) Feasible with modification - continue main study with modifications, 3) Feasible without modification - no modifications but close monitoring, 4) Feasible as is - continue without modifications.
Recruitment (Process and resources):
时间窗: Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
* Enrolment rate - how many of the eligible patients (given full trial information) end up as participants (signed informed consent) * Barriers to participation - why do patients decline to enroll (enquired when they decline participation when given full trial information) * Retention rate - how many participants complete the 12-week follow-up * Barriers to retention - why do participants decide to discontinue participation in the trial * Eligibility criteria - how many participants drop out after enrolment * Trial measures - how many participants have blank/incomplete/complete tests and questionnaires
次要结局
- Trial personnel feasibility (Management/Scientific)(Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery)
- Harms (Scientific)(Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery)
- Participant symptom guide follow-up(Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery)
- Participant (patient) experiences and experienced acceptability; of their allocated intervention(Interviews will be conducted after participants complete the 12 week follow-up)
研究者
Birk Mygind Grønfeldt
PhD Fellow
Copenhagen University Hospital, Hvidovre