Effects of Community Occupational Therapy on the Daily Performance of Older Patients With Mild to Moderate Dementia and on the Sense of Competence of Their Primary Caregivers.
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- 1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
研究概览
简要总结
The purpose of this study is to determine the effects of community occupational therapy in older patients with mild ot moderate dementia and their primary caregivers.
详细描述
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Objective To determine the effects of community occupational therapy on the daily performance of older patients with mild to moderate dementia and the sense of competence of their primary caregivers.
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Methods
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design: a randomized controlled single-blind design is used with 3 measurement moments. We measure at baseline (before start of OT intervention), after 6 weeks (the effect measurement)and after 3 months after baseline (follow-up measurement).
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patients: 135 patients and their primary caregivers are needed to determine effects on the primary outcome measures of this intervention, with a power of 80% and alpha = 0.05/3. This power calculation is based on the outcomes of a pilot study (Graff, et al., 2003).
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intervention: 5 weeks client-centered community occupational therapy directed at both patients and primary caregivers using an OT guideline.The control group receives no OT intervention, but usual care.
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main outcome measures are: Assessment of Motor and Process Skills, Interview in Deterioration of Daily Activities in Dementia (IDDD)and Sense of Competence Questionnaire (SCQ)
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Analysis: analyses of covariance on intention-to-treat basis (Last Observation Carried Forward (LCOF))will be used to determine the effects of community OT on the daily performance of older patients with dementia and the sense of competence of their primary caregivers. Also secondary patients'and caregivers' health outcomes will be analyzed by analyses of covariance on intention-to-treat basis.
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Cost-effectiveness: the costs of this OT intervention will also be determined and a cost-effectiveness analysis will be carried out.
3)Results: Results at baseline, at 6 weeks and at 3 months follow-up on primary outcome measures and on patients' and caregivers' secondary health outcomes and also the cost effectiveness of this intervention, will be analyzed and described in international publications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 years or older
- •mild to moderate dementia (MMSE 10-24)
- •living in the community at maximum of 50 kilometers from the Memory Clinic
- •having an informal primary caregiver who was involved in the care for the patient at least once a week
排除标准
- •depression: score > 12 on the Geriatric Depression Scale
- •severe behavioral or psychological symptoms in dementia (BPSD) judged by a geriatrician
- •severe illnesses, judged by a geriatrician
- •no OT goals, determined by the researcher or research assistant
- •caregivers having severe illnesses
结局指标
主要结局
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);
3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
次要结局
- Patients:
- 1. motor skills scores on the AMPS
- 2. initiative in performing daily activities on the IDDD
- 3. general health scores on the General Health Questionnaire (GHQ-12)
- 4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)
- 5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)
- 6. Mood/depression scored on the Cornell Depression Scale (CDS)
- Caregiver:
- 1. mastery skills scored on the Mastery Scale
- 2. general health scores on the GHQ-12
- 3. quality of life scores on the DQOL
- 4. self-perception scores in occupational performance and satisfaction scores on the COPM
- 5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)
- 6. Copings skills scores on the JCS