Copenhagen University, Bispebjerg and Frederiksberg Hospital, The Parker Institute, Copenhagen, Denmark
Department of Public Health, University of Southern Denmark, Odense, Syddanmark, Denmark.
BMJ Open. 2021 Nov 26;11(11):e051722. doi: 10.1136/bmjopen-2021-051722.
The need to develop and evaluate interventions, addressing problems performing activities of daily living (ADL) among persons with chronic conditions, is evident. Guided by the British Medical Research Council's guidance on how to develop and evaluate complex interventions, the occupational therapy programme (A Better everyday LifE (ABLE)) was developed and feasibility tested. The aim of this protocol is to report the planned design and methods for evaluating effectiveness, process and cost-effectiveness of the programme.
The evaluation is designed as a randomised controlled trial with blinded assessors and investigators. Eighty participants with chronic conditions and ADL problems are randomly allocated to ABLE or usual occupational therapy. Data for effectiveness and cost-effectiveness evaluations are collected at baseline (week 0), post intervention (week 10) and follow-up (week 26). Coprimary outcomes are self-reported ADL ability (ADL-Interview (ADL-I) performance) and observed ADL motor ability (Assessment of Motor and Process Skills (AMPS)). Secondary outcomes are perceived satisfaction with ADL ability (ADL-I satisfaction); and observed ADL process ability (AMPS). Explorative outcomes are occupational balance (Occupational Balance Questionnaire); perceived change (Client-Weighted Problems Questionnaire) and general health (first question of the MOS 36-item Short Form Survey Instrument). The process evaluation is based on quantitative data from registration forms and qualitative interview data, collected during and after the intervention period. A realist evaluation approach is applied. A programme theory expresses how context (C) and mechanisms (M) in the programme may lead to certain outcomes (O), in so-called CMO configurations. Outcomes in the cost-effectiveness evaluation are quality-adjusted life years (EuroQool 5-dimension) and changes in ADL ability (AMPS, ADL-I). Costs are estimated from microcosting and national registers.
Danish Data Protection Service Agency approval: Journal-nr.: P-2020-203. The Ethical Committee confirmed no approval needed: Journal-nr.: 19 045 758. Dissemination for study participants, in peer-reviewed journals and conferences.
NCT04295837.
显然，需要开发和评估干预措施，以解决患有慢性疾病的人在进行日常生活活动（ADL）方面的问题。在英国医学研究理事会关于如何开发和评估复杂干预措施的指南的指导下，开发并测试了职业治疗方案（A Better everyday LifE (ABLE)）。本方案旨在报告该方案的有效性、过程和成本效益评估的计划设计和方法。
该评估设计为随机对照试验，评估人员和研究人员均为盲法。80 名患有慢性疾病和 ADL 问题的参与者被随机分配到 ABLE 或常规职业治疗组。在基线（第 0 周）、干预后（第 10 周）和随访（第 26 周）时收集有效性和成本效益评估的数据。主要结局指标是自我报告的 ADL 能力（ADL-Interview (ADL-I) 表现）和观察到的 ADL 运动能力（Assessment of Motor and Process Skills (AMPS)）。次要结局指标是对 ADL 能力的感知满意度（ADL-I 满意度）和观察到的 ADL 过程能力（AMPS）。探索性结局指标是职业平衡（Occupational Balance Questionnaire）、感知变化（Client-Weighted Problems Questionnaire）和总体健康状况（MOS 36 项简短表格调查工具的第一个问题）。过程评估基于干预期间和之后收集的登记表格和定性访谈数据中的定量数据。应用了一种现实主义评估方法。方案理论表达了方案中的情境（C）和机制（M）如何导致某些结果（O），形成所谓的 CMO 配置。成本效益评估中的结果是生活质量调整生命年（EuroQool 五维）和 ADL 能力的变化（AMPS、ADL-I）。成本根据微观成本和国家登记册进行估算。
丹麦数据保护局批准：期刊编号：P-2020-203。伦理委员会确认无需批准：期刊编号：19 045 758。研究参与者在同行评议期刊和会议上进行传播。
NCT04295837。
