NCT00295152

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
Last Updated

November 17, 2011

Status Verified

February 1, 2006

First QC Date

February 21, 2006

Last Update Submit

November 16, 2011

Conditions

Keywords

elderly/agedoccupational therapydaily activitiescaregiverssense of competence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memory Clinic and Geriatic Department Radboud University Nijmegen Medical Centre

Nijmegen, PO Box 9101, 6500 HB, Netherlands

Location

Related Publications (10)

  • 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.

    PMID: 12937332BACKGROUND
  • 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.

    PMID: 15315918BACKGROUND
  • 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.

    PMID: 9988301BACKGROUND
  • 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.

    PMID: 11246648BACKGROUND
  • 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.

    PMID: 9447438BACKGROUND
  • 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.

    RESULT
  • 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.

    RESULT
  • 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

    RESULT
  • 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.

    RESULT
  • 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.

Study Officials

  • Marcel GM Olde-Rikkert, PhD, MD

    Department of Geriatrics Radboud University Nijmegen Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

April 1, 2001

Study Completion

February 1, 2005

Last Updated

November 17, 2011

Record last verified: 2006-02

Locations