Evaluation of mHealth supported intervention for rehabilitation monitoring after knee replacement – An open-label randomised controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient reported knee function
研究概览
简要总结
Monitoring of Physical rehabilitation is an essential component of patient recovery after knee arthroplasty~~.~~ Monitoring can be remote or clinic-based. In India, unsupervised home-based physical rehabilitation is a common practice, and there is lack of evidence to demonstrate effectiveness of remote monitoring of rehabilitation. Therefore, we developed and piloted a mobile application [Tele REhabilitation after knee ArThroplasty (TReAT app)] based on behavior design-design thinking approach to support the recovery period. The TReAT app consists of five components: knowledge, skills, self-management & motivation, communication with healthcare providers, and monitoring by healthcare providers. Weaim to compare the effectiveness, acceptability, cost, and safety of this app-based intervention against usual care (home-based with various levels of in-person supervision in clinic) using open label, 1:1 individual randomized superiority trial at two tertiary care hospitals in Delhi.
The primary objective would be to compare patient reported knee function between the two groups at 3- and 6-months post-surgery. Additionally, we will also compare patient reported outcomes (pain, falls), performance-based outcomes (lower limb strength and function), knowledge about recovery, rehabilitation adherence, satisfaction with surgery, resource utilization and cost, quality of life. End user experience and fidelity of the implementation will be measured using both quantitative and qualitative methods.
Consecutive adult patients undergoing partial or total (unilateral or bilateral) knee arthroplasty at each of the hospitals (one unit) will be screened for eligibility. Consenting individuals will be randomized to either app-supported intervention or usual care group. The target sample size is 300 patients, to be recruited over a period of one year. Data will be collected at baseline, 3 months, and 6 months post-surgery by a trained research coordinator. Anonymous quantitative data will be entered and stored in a web-based electronic data capture system. Qualitative data will be stored securely in password protected folders and data will be anonymized before analysis to maintain patient confidentiality. Quantitative data will be analysed in Stata17, and group comparisons will be done using mixed effect linear regression. Qualitative data will be analyzed via an inductive-deductive approach using NVivo software.
The trial is funded by DBT-Wellcome trust India alliance and trial will be initiated after obtaining ethical approvals from The George Institute for global health (Sponsor), India, All India Institute of Medical Sciences, Delhi and Indraprastha Apollo Hospital, Delhi. All ethical guidelines will be followed related to voluntary informed consent and data confidentiality laid by ICMR for conduct of research on human participants. The trial will be insured, and any trial related harm will be compensated. Participants will be provided monetary compensation for trial specific hospital visits as per institutional norms and ethical guidelines.
This intervention can be incorporated into routine clinical practice for remote supervision of home-based rehabilitation given it is proven to be clinically effective, safe, cost effective and accepted by the end users. This would serve the aim of improving patient experience and aid in faster recovery post knee arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (aged ≥ 18 years) scheduled for primary partial or total (unilateral or bilateral) knee arthroplasty indicated for knee arthritis.
- •Patient has access to a smartphone and internet connection
- •Patient or any of the family members living in the same household is familiar with navigating a smartphone and able to use common features such as video calling, messaging, and camera
- •Patients able to speak and read English or Hindi language.
排除标准
- •Revision knee arthroplasty
- •Knee replacement indicated for trauma, tuberculosis of knee joint or other septic arthritis
- •Patients who are unable to make a hospital visit at 3 and 6 months after surgery
- •Patients who have severe cognitive impairment precluding ability to provide fully informed consent
- •Uncorrectable hearing and visual impairment
- •Not willing to be randomized to the rehabilitation approaches.
结局指标
主要结局
Patient reported knee function
时间窗: 3 and 6 months
次要结局
- Balance(3 and 6 months)
- knee pain(3 and 6 months)
- Knee range of motion(3 and 6 months)
- Gait speed and stability(3 and 6 months)
- Lower limb strength(3 and 6 months)
- Lower extremity activity level(3 and 6 months)
- Safety (number of falls)(3 and 6 months)
- Patient experience(6 months)
- Cost effect and utility(3 months)
研究者
Dr Niveditha Devasenapathy
The George Institute for Global Health INDIA