Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy for Improving Activities of Daily Living in People With Chronic Conditions: A Protocol for a Randomized Controlled Pilot and Feasibility Study (The Go:OT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in observed motor ability
研究概览
简要总结
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. Municipality occupational therapy interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective, a group-based intervention format might be as effective but more cost-effective? Hence, the group-based ADAPT program was developed, piloted and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness. A randomized controlled trial (RCT) is however needed to document effectiveness, processes, and cost-effectiveness of the ADAPT program versus usual occupational therapy (UOT) for people with chronic conditions. Prior to the RCT, this pilot and feasibility study will be conducted to test aspects of trial design, conduct and processes as well as intervention content and delivery.
Material and Methods: A total of 16 home dwelling persons with chronic conditions, experiencing ADL task performance problems will be randomized and allocated to receive ADAPT (intervention) or UOT (control). Effectiveness and cost-effectiveness assessments are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Pilot and feasibility aspects will be evaluated by means of registrations forms filled out by the OTs delivering ADAPT and people with chronic conditions attending ADAPT. Registrations are designed to inform aspects of 1) recruitment and retention, 2) trial participation, 3) impact of trial on participants and staff, 4) completion rates, 5) fidelity and dose 6) assesable information and 7) adaptation of trial conduct to local context. Progression criteria for when to 'go', 'amend' or 'be alert/stop' are defined, to support the decision on whether to continue to RCT or the need to adjust design or procedures,
详细描述
TThe specific aims of this pilot and feasibility study are to evaluate:
- how recruitment procedures work and if participants accept randomization (recruitment and retention)
- if clients feel adequately informed about the purpose of the assessments done and the content and time use regarding interventions delivered (trial participation)
- if trial participation has unanticipated impacts on ADAPT OTs (e.g. workload) (Impact of trial on staff)
- if registration forms and outcome measurements are completed (Completion rates)
- the extent of which the ADAPT OT adhere to the ADAPT program manual and deliver key components within each session (fidelity and dose)
- if data informing about intervention delivered in UOT is accessible from client records (Assessable information)
- if ADAPT OTs perceive organizational factors to facilitate or hinder program delivery (adaptation of trial conduct to local context)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The trial attempts to blind clients and assessors. Clients 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 the format i.e. a group-based versus a one-to-one intervention program. Clients are however not informed, which of the two types of formats that are the new experimental intervention format (ADAPT). Baseline assessments are conducted prior to randomization by the local project coordinator and the project coordinator is instructed not to reveal which intervention that is the new experimental intervention. The post- and follow-up assessor, an externally recruited occupationa therapist from a nearby hospital research unit, is also instructed not to disclose which intervention that is the new. Finally, all clients are reminded not to disclose any details, that may provide the outcome assessor with insight regarding their group allocation.
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
- •≥ 18 years of age
- •≥ 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 on the AMPS ADL motor skills scale (indicate increased effort during ADL task performance)
- •Communicate independently and relevantly orally and in writing (without severe cognitive deficits, aphasia, significant hearing loss or dyslexia)
- •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
- •Mental illness and/or other acute (<3 months) conditions effecting ADL task performance
- •Language barriers
- •Known substance abuse
结局指标
主要结局
Change in observed motor ability
时间窗: week 12
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
次要结局
- Perceived change ability to problemsolve(week 12 and 26)
- Change in self-reported satisfaction with ability to perform activities of daily living tasks-(week 12 and 26)
- Perceived change in occupational balance(week 12 and 26)
- Change in observed motor ability(week 26)
- Perceived change in ability to perform activities of daily living tasks(week 12 and 26)
- Perceived generel health(week 12 and 26)
- Change in self-reported ability to perform activities of daily living tasks(week 12 and 26)
- Perceived change in need for assistance(week 12 and 26)
- Perceived change in Quality fo life(week 12 and 26)
- Perceived Quality of life(week 12 and 26)
- Change in observed process ability(week 12 and 26)
研究者
Eva Ejlersen Wæhrens
Professor
Parker Research Institute