Evaluating Group-based (ADAPT) Versus One-to-one (Usual) Occupational Therapy on Ability to Perform Activities of Daily Living (ADL) in People With Chronic Conditions (Go:OT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)
研究概览
简要总结
This trial aims to evaluate the ADAPT Program in terms of efficacy, process and cost-efficacy compared to usual occupational therapy (UOT) in people with decreased ability to perform activities of daily living (ADL) following chronic conditions. As both the ADAPT Program and UOT are targeted improvements in ADL ability, the primary objective of this trial is to assess equivalence between the ADAPT Program and UOT on changes in ADL ability as measured with the Assessment of Motor and Process Skills (AMPS).
详细描述
Background: The number of people living with chronic conditions limiting the ability to perform activities of daily living (ADL) tasks is increasing. Occupational therapists are trained to deliver interventions to improve ADL ability, e.g. by adapting and adjusting daily routines and physical environments. Municipality occupational therapy (OT) interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective in improving ADL ability, a group-based intervention format might be as effective but more cost-effective and hold other secondary gains. Guided by the British Medical Research Council's guidance (MRC) on how to develop and evaluate complex interventions, the ADAPT Program, a peer-exchange group-based program, was developed, piloted, and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness in improving ADL ability and suggests gains as improved well-being. Hence, the current phase concerns a full-scale evaluation of the ADAPT Program including evaluation of effectiveness, processes and cost-effectiveness.
Material and Methods: The randomized controlled trial (RCT), initiated with an external pilot (n=12), will include 130 home dwelling persons with decreased ADL ability following chronic conditions. Participants are randomized to either ADAPT Program (experimental) or usual OT (control).
Primary outcome: Observed ADL motor ability measured with the Assessment of Motor and Process Skills (AMPS).
Secondary outcomes: Observed ADL process ability measured with the AMPS; patient reported ADL task Performance and Satisfaction measured with the ADL-Interview (ADL-I, Performance and Satisfaction scores); Well-being assessed with the World Health Organisation-Five Well Being Index (WHO-5); Health-related Quality of Life assessed with the European Quality of Life - 5 Dimensions (EQ-5D).
Exploratory outcomes include patient reported changes, using transition scales to evaluate participants´ experience of a) changed ADL task performance and satisfaction, b) changed problem-solving skills, c) changed quality of life, d) changed global health, e) changed needs for assistance. Finally, participants are to rate their overall experience of the allocated occupational therapy intervention.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are informed that they will be allocated to one of two occupational therapy intervention programs that both aims to improve ADL ability, but overall primarily differ in terms of their format i.e. a group-based versus a one-to-one intervention program format. Participants are not informed, which of the two types of formats that are the new experimental intervention format (ADAPT) nor control (UOT). Baseline assessments are conducted prior to randomization by a local employed occupational therapists, who is instructed not to reveal which intervention that is the new experimental intervention. The post and follow-up assessors, a research occupational therapy assistant employed at the Parker Institute, is also instructed not to disclose which intervention that is the new experimental one. Finally, all participants are reminded not to disclose any details, that may provide the outcome assessors with insights regarding their allocated study arm.
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.
- •Lives in own home.
- •Experience ADL task performance problems.
- •Show ADL motor ability measures <1.50 logits on the AMPS ADL motor skill scale (indicate increased effort during ADL task performance).
- •Communicate independently and relevantly orally and in writing.
- •Willing and interested in attending occupational therapy interventions focused on improving ADL task performance.
排除标准
- •ADL process ability measures <0.00 indicating that the person is unlikely to profit from educational programs focused on using adaptational strategies.
- •Personal ADL (PADL) problems with acute need for help.
- •Mental illness and/or other acute (<3 months) conditions effecting ADL task performance significantly.
- •Significant communication barriers (significant cognitive deficits, -aphasia, -hearing loss, -dyslexia and/or -language barriers).
- •Known substance abuse.
研究组 & 干预措施
ADAPT Program
The ADAPT Program is a structured and individualized group-based program
干预措施: The ADAPT Program (Behavioral)
Usual Occupational Therapy (UOT)
UOT is delivered by one occupational therapist in the clients homes or local environments. .
干预措施: UOT (Behavioral)
结局指标
主要结局
Change in observed ADL motor ability, Assessment of Motor and Process Skills (AMPS)
时间窗: week 12
Observation-based ADL motor ability (reflecting physical effort and independence ). Linear measures of ADL motor ability generated using Rasch measurement models. Higher scores mean better ADL ability
次要结局
- Change in self-reported ADL ability, using the ADL-Interview (ADL-I), Performance scale(week 12)
- Well-being, using The World Health Organisation- Five Well-Being Index (WHO-5)(week 26)
- Change in observed ADL process ability, using AMPS(week 26)
- Change in self-reported ADL ability with ADL-I, Performance scale(week 26)
- Quality of life, using the EuroQoL 5 dimensions (EQ-5D)(week 12)
- Quality of life, using EQ-5D(week 26)
- Change in observed ADL motor ability, using AMPS(week 26)
- Change in self-reported satisfaction with ADL ability, using ADL-I, Satisfaction scale(week 12)
- Change in self-reported satisfaction with ADL ability, using the ADL-Interview (ADL-I), Satisfaction scale(week 26)
- Well-being, using the World Health Organisation- Five Well-Being Index (WHO-5)(week 12)
- Change in observed ADL process ability, using AMPS(week 12)
研究者
Eva Ejlersen Wæhrens
Senior researcher, Associate Professor
Parker Research Institute