Strategy-based Cognitive Intervention for Parkinson Disease: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change in Bangor Goal Setting Interview (BGSI) Goal Attainment
研究概览
简要总结
Parkinson disease (PD) affects over 1 million Americans and causes considerable personal and socioeconomic costs (>$34 billion/year in the US) that are expected to rise as the population ages. Cognitive impairment produces disability and reduced quality of life among non-demented people with PD. Surgical and pharmacologic treatments for PD do not prevent or treat cognitive impairment and may even exacerbate the problem. As such, cognitive rehabilitation treatments that mitigate its negative functional consequences are a top research priority.
Unfortunately, existing cognitive rehabilitative programs for PD, which focus on restoring deficient cognitive processes through process training (repetitive practice of tasks that challenge specific cognitive processes), have had limited effect on daily function. To overcome this limitation, the investigators take a strategy training approach. Trained occupational therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities. Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury; however, it has not been studied in PD. By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context, the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training.
The investigators developed MultiContext for PD (MC4PD) to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function. MC4PD is an individualized, community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer. In an iterative case series, the investigators fine-tuned the treatment protocol, established good participant acceptance and engagement, and provided preliminary data on its benefits for daily cognitive function. The next step is to confirm MC4PD's feasibility in a randomized controlled trial (RCT). In this project, the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment (Control). Individuals with PD will complete pre-treatment testing, randomization to treatment group, 10 treatment sessions, and immediate and 3 months post-treatment testing.
详细描述
Parkinson disease (PD) affects over 1 million Americans and causes considerable personal and socioeconomic costs (>$34 billion/year in the US) that are expected to rise as the population ages. Cognitive impairment produces disability and reduced quality of life among non-demented people with PD. Surgical and pharmacologic treatments for PD do not prevent or treat cognitive impairment and may even exacerbate the problem. As such, cognitive rehabilitation treatments that mitigate its negative functional consequences are a top research priority.
Unfortunately, existing cognitive rehabilitative programs for PD, which focus on restoring deficient cognitive processes through process training (repetitive practice of tasks that challenge specific cognitive processes), have had limited effect on daily function. To overcome this limitation, the investigators take a strategy training approach. Trained Occupational Therapists teach people targeted strategies to use in everyday life to circumvent cognitive deficits and accomplish meaningful daily activities. Contemporary cognitive rehabilitation evidence supports this approach for people with chronic neurocognitive dysfunction from stroke and brain injury; however, it has not been studied in PD. By teaching strategies for everyday cognition and using training techniques to support transfer of learning beyond the training context, the investigators hypothesize that our strategy training interventions will produce better functional outcomes for people with PD compared to process training.
The investigators developed MultiContext for PD (MC4PD) to enable people with PD to apply strategies in their everyday lives to cope with cognitive decline and improve or maintain daily function. MC4PDis an individualized, community-based intervention that focuses on the attainment of personally meaningful functional goals using training techniques known to enhance strategy learning and transfer. In an iterative case series, the investigators fine-tuned the treatment protocol, established good participant acceptance and engagement, and provided preliminary data on its benefits for daily cognitive function. The next step is to confirm MC4PD's feasibility in a randomized controlled trial (RCT). In this project, the investigators will assess feasibility and treatment fidelity and generate data in preparation for a definitive RCT by conducting a single-blind pilot RCT comparing MC4PD to a standard-of-care treatment (Control). Individuals with PD (N = 60) will complete pre-treatment testing, randomization to treatment group, 10 treatment sessions, and immediate and 3 months post-treatment testing.
Aim 1: Examine the feasibility of MC4PD within an RCT. H1: Study recruitment will be 4 participants/month, retention in both treatment groups will be 4 participants/month, retention in both treatment groups will be > or equal to 85%, and greater than or equal to 85% of participants in both groups will complete the intervention in 12 weeks. The investigators will track recruitment, retention, intervention duration, and reasons for non-enrollment or attrition throughout the study period.
Aim 2: H2a: Therapists will deliver MC4PD with high adherence and competence. Blinded raters will rate therapist adherence and competence for a random sample (30%, n=180) of MC4PD and Control treatment sessions. The investigators will calculate adherence and competence (to MC4PD) for each therapist; adherence > or equal to 80% and competence greater than or equal to 3 (of 4 possible, indicating at least "Well done") will be benchmarks for good treatment integrity. H2b: MC4PD participants will have good acceptance, receipt, and enactment of treatment. MC4PD participants will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment, and blinded raters will rate participants' session participation (Pittsburgh Rehabilitation Participation Scale; PRPS) and homework completion. CSQ-8 scores greater than or equal to 24 (of 32 possible, indicating all positive responses), PRPS scores greater than or equal to 4 (of 6, indicating at least "Good"), and homework completion rates greater than or equal to 80% will be benchmarks for good acceptance, receipt, and enactment, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomized to treatment arm: the intervention or the standard of care control. Participants will not be informed if their treatment group is the experimental intervention or standard of care.
Both treatments consist of 10, 1-hour sessions over 12 weeks delivered in an individual, face-to-face format in participants' homes and/or communities by trained licensed occupational therapists (OTs).
Members of the research team who are involved in the post-treatment testing will be blinded to which intervention (experimental or control) the study participant received from the trained OT.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females over age 40 who meet criteria for typical idiopathic PD (stage I-III)
- •Have subjective cognitive decline (SCD) as defined by a positive answer to either question: "Do you feel like your thinking skills or memory are becoming worse?" "Do you have problems with your thinking skills or memory?", and can list one or more daily cognitive challenge they wish to address.
- •Medications should be stable for 4 weeks prior with no changes planned during the study (we will document unplanned changes).
排除标准
- •Dementia according to MDS criteria or a Montreal Cognitive Assessment (MoCA) score < 21
- •other neurological disorders
- •brain surgery
- •history of psychotic disorder
- •any condition that would interfere with participation (e.g. non-English speaking, significant current depression)
结局指标
主要结局
Change in Bangor Goal Setting Interview (BGSI) Goal Attainment
时间窗: Pre-cognitive treatment intervention; one week post- cognitive treatment intervention (11 to 13 weeks after the pre-cognitive intervention treatment session); and at 3-months follow-up after the post- cognitive treatment treatment session.
BGSI is a structured interview schedule was used to record participant ratings of performance and satisfaction in reaching specific goals, and to record additional ratings of goal attainment. This instrument rates goal attainment on a ten point scale (1-10) with a higher score indicating higher goal attainment.
次要结局
- Client Satisfaction Questionnaire(Administered one time, one week post- cognitive treatment intervention.)
- Treatment Fidelity Scale(Each of the 10 cognitive treatment intervention sessions. These treatment sessions will be 1 to 1.5 hours in length, and be delivered once a week, to be completed within a 12-week time frame.)