Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Endurance Shuttle Walking Test (ESWT)
研究概览
简要总结
Pulmonary rehabilitation (PR) is a comprehensive, multidisciplinary, individually-tailored intervention that overcomes the deconditioning induced by chronic respiratory diseases (CRDs). In Low- and Middle-Income Counties (LMICs), CRDs may be poorly differentiated, and PR inaccessible and under-resourced. Our objective is to test the clinical/cost effectiveness, sustainability at 6-months, acceptability and implementability of Centre- or Home-PR delivered in lowresource centres for people with CRDs compared to usual care. Four Centres will be participating (Bangladesh, India x2, Malaysia). Total 465 adults with symptomatic CRD will be enrolled. This will be 3-arm individually-randomised, assessor-blinded 6-month hybrid-1 implementation trial, with health economic and process evaluations. Following initial centre-based teaching of personalised exercise/education programme, two approaches to delivering PR:
-
Centre-PR: centre-based sessions twice weekly for 8 weeks
-
Home-PR: Remotely supervised sessions at home twice weekly for 8 weeks
Usual care group: Locally available healthcare (choice of Centre- or Home- PR at the end of the trial)
Primary outcome: Endurance Shuttle Walking Test (ESWT)
Key secondary outcomes: Quality of Life: St Georges Respiratory Questionnaire (SGRQ)
Other outcomes: mMRC Dyspnoea Score; Hospital Anxiety and Depression Score; smoking status; Activities of Daily Living; Physical Activity; adverse events; use of healthcare resources. Researcher-blind assessments (baseline; post-PR; 6-months) will be done.
ESWT will be analysed using a normal linear model, with treatment allocation, baseline ESWT and Centre included as fixed effect covariates. Cost-consequence analysis of health care cost, out of pocket expenses and impact on work productivity. Mixed methods assessment of fidelity/adaptation, mechanisms of action, acceptability and sustainability will be implemented.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Adults 18years old (the age of majority in all the countries).
- •No upper age limit.
- •â€¢ Assessed by referring physician as having persistent and functionally limiting respiratory symptoms (mMRC more than 2) after optimisation of pharmacological therapy.
- •â€¢ Resident locally and willing to engage with either Centre-PR and Home-PR schedules if randomised to either of these groups.
- •â€¢ Willing and able to provide written informed consent.
排除标准
- •â€¢ People with non-respiratory causes for the symptoms (stable co-morbidity may be included if clinically appropriate).
- •â€¢ Active TB infection.
- •â€¢ Any condition that would increase risk (e.g. uncontrolled cardiac disease) interfere with PR (e.g. neurological disorders, severe arthritis, dementia).[44] or be inappropriate (very severe frailty, end-of-life) • On-going, or completed PR (including other exercise programme) within previous 18 months.
- •â€¢ Living in the same house as another participant • Unwilling or unable to provide informed consent.
结局指标
主要结局
Endurance Shuttle Walking Test (ESWT)
时间窗: 8 weeks post intervention and 6 months post intervention
次要结局
- Health related quality of life (HRQoL);anxiety/depression level, breathlessness level, physical activity level(8 weeks post intervention and 6 months post intervention)
研究者
Parag Gajanan Khatavkar
KEM Hospital Research Centre