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Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.

Primary Purpose

Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
community occupational therapy in dementia
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community Occupational Therapy focused on measuring elderly/aged, occupational therapy, daily activities, caregivers, sense of competence

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
February 21, 2006
Last Updated
November 16, 2011
Sponsor
Radboud University Medical Center
Collaborators
Alzheimer's Association, VCVGZ Fund;, Dutch Occupational Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT00295152
Brief Title
Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Alzheimer's Association, VCVGZ Fund;, Dutch Occupational Therapy Association

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. Methods 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). 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). 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. 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) 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Occupational Therapy, Dementia Patients, Primary Caregivers of Dementia Patients
Keywords
elderly/aged, occupational therapy, daily activities, caregivers, sense of competence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
135 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
community occupational therapy in dementia
Primary Outcome Measure Information:
Title
1.process skills scores of the patients on the Assessment of Motor and Process Skills (AMPS);
Title
2. performance scores in daily activities of the patients on the Interview of Deterioration in Daily Activities in Dementia (IDDD);
Title
3. Sense of competence scores of the primary caregivers on the Sense of Competence Questionnaire (SCQ).
Secondary Outcome Measure Information:
Title
Patients:
Title
1. motor skills scores on the AMPS
Title
2. initiative in performing daily activities on the IDDD
Title
3. general health scores on the General Health Questionnaire (GHQ-12)
Title
4.Quality of life scored on the Dementia Quality of Life Instrument (DQOL)
Title
5. Self-perception scores in occupational performance and satisfaction scores with this performance, scored on the Canadian Occupational Performance Measurement (COPM)
Title
6. Mood/depression scored on the Cornell Depression Scale (CDS)
Title
Caregiver:
Title
1. mastery skills scored on the Mastery Scale
Title
2. general health scores on the GHQ-12
Title
3. quality of life scores on the DQOL
Title
4. self-perception scores in occupational performance and satisfaction scores on the COPM
Title
5. mood/depression scores on the Center for Epidemiologic Studies Depression Scales (Ces-D)
Title
6. Copings skills scores on the JCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel GM Olde-Rikkert, PhD, MD
Organizational Affiliation
Department of Geriatrics Radboud University Nijmegen Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
PO Box 9101, 6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12937332
Citation
Gitlin LN, Winter L, Corcoran M, Dennis MP, Schinfeld S, Hauck WW. Effects of the home environmental skill-building program on the caregiver-care recipient dyad: 6-month outcomes from the Philadelphia REACH Initiative. Gerontologist. 2003 Aug;43(4):532-46. doi: 10.1093/geront/43.4.532.
Results Reference
background
PubMed Identifier
15315918
Citation
Steultjens EM, Dekker J, Bouter LM, Jellema S, Bakker EB, van den Ende CH. Occupational therapy for community dwelling elderly people: a systematic review. Age Ageing. 2004 Sep;33(5):453-60. doi: 10.1093/ageing/afh174.
Results Reference
background
PubMed Identifier
9988301
Citation
Vernooij-Dassen MJ, Felling AJ, Brummelkamp E, Dauzenberg MG, van den Bos GA, Grol R. Assessment of caregiver's competence in dealing with the burden of caregiving for a dementia patient: a Short Sense of Competence Questionnaire (SSCQ) suitable for clinical practice. J Am Geriatr Soc. 1999 Feb;47(2):256-7. doi: 10.1111/j.1532-5415.1999.tb04588.x. No abstract available.
Results Reference
background
PubMed Identifier
11246648
Citation
Vernooij-Dassen M, Lamers C, Bor J, Felling A, Grol R. Prognostic factors of effectiveness of a support program for caregivers of dementia patients. Int J Aging Hum Dev. 2000;51(4):259-74. doi: 10.2190/P8L1-N8QD-VTJ4-EURT.
Results Reference
background
PubMed Identifier
9447438
Citation
Teunisse S, Derix MM. The interview for deterioration in daily living activities in dementia: agreement between primary and secondary caregivers. Int Psychogeriatr. 1997;9 Suppl 1:155-62. doi: 10.1017/s1041610297004845.
Results Reference
background
Citation
Graff MJL, et al.Occupational therapy at home for older individuals with mild to moderate cognitive impairments and their primary caregivers: a pilot study. Occupational Therapy Journal of Research 23, 155-163, 2003.
Results Reference
result
Citation
Graff MJL, Melick van MBM. The development, testing and implementation of an occupational therapy guideline. The guideline for the OT diagnosis and treatment of older persons with cognitive impairments. Ducth Occupational Therapy Journal 28, 169-174, 2000.
Results Reference
result
Citation
Melick van MBM, Graff MJL. Occupational therapy for geriatric patients. The guideline for occupational therapy in geriatric patients with mild to moderate cognitive impairments. Dutch Journal of Occupational Therapy 28, 176-181, 2000
Results Reference
result
Citation
Graff MJL, et al. How can occupational therapy improve the daily performance and communication of an older patient with dementia and his primary caregiver: a case study. Dementia: the journal of social research and practice. 2006. In press.
Results Reference
result
PubMed Identifier
17114212
Citation
Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Rikkert MG. Community based occupational therapy for patients with dementia and their care givers: randomised controlled trial. BMJ. 2006 Dec 9;333(7580):1196. doi: 10.1136/bmj.39001.688843.BE. Epub 2006 Nov 17.
Results Reference
derived

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Effects of Community Occupational Therapy in Older Patients With Dementia and Their Caregivers.

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