A Better Everyday Life - a Complex Intervention Addressing Ability to Perform Activities of Daily Living Among Persons Living With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
研究概览
简要总结
Background: Persons living with chronic conditions often have decreased ability to perform Activities of Daily Living (ADL) tasks, stressing a need to develop and evaluate intervention programs addressing decreased ADL ability. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the program "A Better everyday LifE" (ABLE), a home-based intervention program, was developed and feasibility tested. The current phase concerns a full-scale evaluation of the ABLE program including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The design involves a randomized controlled trial, initiated with an internal pilot. The study will include eighty (n=80) home dwelling persons living with chronic conditions, experiencing problems performing ADL. Participants are randomized to either intervention (ABLE) or control (usual care).
Co-primary outcomes are self-reported ADL ability measured using ADL-Questionnaire (ADL-Q) and observed ADL motor ability measured using Assessment of Motor and Process Skills (AMPS). Secondary outcomes are perceived satisfaction with ADL task performance measured using ADL-Q; observed ADL process ability measured using AMPS; and Goal Attainment measured using Goal-Attainment-Scaling (GAS). Data is collected at baseline, post intervention and six months after baseline. Process evaluation data are collected using registration forms and semi-structured qualitative interviews.
The economic evaluation will be performed from a health care sector perspective with 6 months follow-up. Costs will be estimated based on micro costing and national registries. Effects will be Quality Adjusted Life Years and changes in AMPS ADL ability.
详细描述
Due to the Covid-19 pandemic, the study was truncated on March 11th 2020. Data collected at this time was assessed to be sufficient to answer most pilot study questions, and it was decided to turn the internal pilot into an external pilot. Based on the results of the external pilot, a few adjustments on outcome measurements, inclusion criteria and extraction of information on usual care were applied, before initiation of the full scale trial. Hence ADL-I replaced ADL-Q as primary outcome measurement. Data collection for full scale trial was initiated August 1st 2020.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •≥ one year since medical diagnosed with one or more chronic conditions
- •Perceive problems performing ADL tasks
- •≥ 18 years of age
- •Lives in own home
- •Motivated and ready for making changes in ADL performance
- •Motivated and ready to participate in program
- •Communicates independently and relevant
- •Able to understand and relevantly answer a questionnaire
排除标准
- •PADL problems with acute need for help (if the client does not already receive help from home carer
- •Known substance abuse
- •Mental illness, and/or other acute illness effecting ADL task performance
- •Communication barriers (e.g. severe cognitive deficits; and barriers that prevents receiving information on study)
结局指标
主要结局
Change in observed ADL motor ability - with the Assessment of Motor and Process Skills (AMPS)
时间窗: Week 10
Observation-based measure of ADL ability - motor
Change in self-reported ADL ability - with the ADL-Interview (ADL-I)
时间窗: Week 10
Self-report based on interview addressing perceived ability to perform ADL tasks. Linear measures of ADL ability will be generated using Rasch measurement models. Higher scores mean more ADL ability.
次要结局
- Change in self-reported ADL ability - with the ADL-Interview (ADL-I)(Week 27)
- Change in observed ADL process ability - with the Assessment of Motor and Process skills (AMPS)(Week 27)
- Change in observed ADL motor ability - with the Assessment of Motor and Process skills (AMPS)(Week 27)
- Change in self-reported satisfaction with ADL ability - with the ADL-Interview (ADL-IS)(Week 27)
研究者
Eva Ejlersen Wæhrens
Senior researcher, associate professor
Parker Research Institute