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

• ClinicalTrials.gov Identifier: NCT00295152
• Recruitment Status: Unknown
• First Posted: February 22, 2006
• Last Update Posted: November 17, 2011
• Sponsor: Radboud University Medical Center
• Collaborators: Alzheimer's Association; VCVGZ Fund;; Dutch Occupational Therapy Association
• Information provided by: Radboud University Medical Center

Tracking Information

• First Submitted Date: February 21, 2006
• First Posted Date: February 22, 2006
• Last Update Posted Date: November 17, 2011
• Study Start Date: April 2001
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: February 21, 2006)

• 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 21, 2006)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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

1. 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.

2. Methods

   1. 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).
   2. 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).
   3. 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.
   4. 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)
   5. 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.

   6. 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single; Primary Purpose: Treatment

Condition

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

• Intervention: Behavioral: community occupational therapy in dementia
• Study Arms: Not Provided

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment (submitted: February 21, 2006): 135
• Original Enrollment: Same as current
• Study Completion Date: February 2005
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00295152
• Other Study ID Numbers: EDO project; Grant V-1999-023.
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Radboud University Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Alzheimer's Association
• VCVGZ Fund;
• Dutch Occupational Therapy Association

Investigators

• Principal Investigator: Marcel GM Olde-Rikkert, PhD, MD; Department of Geriatrics Radboud University Nijmegen Medical Centre

• PRS Account: Radboud University Medical Center
• Verification Date: February 2006