NCT01117285

Brief Summary

The main purpose of this cluster randomized controlled trial is to evaluate the difference in effectiveness between a combined implementation strategy and an educational strategy on the implementation of a community occupational therapy program for clients with 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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration 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

October 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 21, 2010

Status Verified

March 1, 2010

Enrollment Period

2.2 years

First QC Date

May 3, 2010

Last Update Submit

May 20, 2010

Conditions

Keywords

Occupational TherapyEvidence-Based PracticeContinuing EducationutilizationGuidelineDementiaGuideline implementation

Outcome Measures

Primary Outcomes (3)

  • Adherence of occupational therapists to the COTiD program

    Adherence is measured using vignettes. Vignettes are realistic case descriptions about which occupational therapists are asked to answer open ended questions.

    one year (baseline, T1, and T2)

  • Community occupational therapy use according to the COTiD program

    Community OT use reflects: * How many people with dementia were referred to OT services in total * How many people with dementia were referred specifically to OT according to the COTiD program.

    one year

  • Costs of the implementation strategies

    The following cost data is collected: Costs of the implementation strategies * Costs made by the OTs, managers, and physicians receiving the combined implementation strategy. * Costs made by the OTs receiving only the educational strategy. * Development and execution costs of the combined implementation strategy. * development and execution costs of the educational strategy. Costs made buy the cliënt and caregiver * Costs made by client and caregiver (using the RUD Lite instrument)regarding healthcare consumption * Time the caregiver spends om informal care

    October 2009 - December 2011

Secondary Outcomes (2)

  • Knowledge of the healthcare professionals about the COTiD program

    one year (baseline, T1, and T2)

  • COTiD program treatment outcome on client and caregiver level

    one year (baseline, T1, and T2)

Study Arms (2)

3-day post-graduate course

ACTIVE COMPARATOR

3-day post-graduate course on the use of the COTiD program in clinical practice

Other: 3-day post-graduate course

Combined implementation strategy

EXPERIMENTAL

The combined implementation strategy

Other: Combined implementation strategy

Interventions

A 3-day course in using the COTiD program in clinical practice. The 3 days are not provided uninterrupted but there are at least two weeks between each day to provide time to practice with the guideline (for discussion on the 2nd day). The course consists of theory on the content of the guideline and its effectiveness, Practice parts of the guideline by rol playing, and discussing each others skills through watching video material.

Also known as: educational strategy
3-day post-graduate course

The combined implementation strategy provides strategies for occupational therapists (OTs), physicians, and managers. OTs receive: * 3-day post-graduate course * 2 extra training days: Lectures and skills practice focused on using the COTiD program and promoting the use of the program within their organization and network. * Coaching on the job: Barriers to using the COTiD program in practice are discussed using motivational interviewing. * Discussion platform * Web-based registration system: Provides guidance in using the COTiD program for every individual client. * Regional meetings: successes and difficulties in using the COTiD are discussed. Managers and physicians receive: * Information on the COTiD program through a website and newsletters. * Motivational reminders.

Also known as: implementation training
Combined implementation strategy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Criteria for clusters
  • The organization provides outpatient OT.
  • The organization expects that they will be able to include a minimum of 8 clients in the study.
  • There are at least two OTs, one manager, and one physician willing and able to participate in the study.
  • The organization does not provide OT or outpatient treatment and is not allowed to refer to OT services in their area that do provide community OT.
  • Less than 8 clients are available per year to refer to the OT.
  • Physicians, managers or OTs are not willing to participate
  • Members of the board of directors responsible for the organization do not agree to participate
  • Criteria for client with dementia and their informal caregiver
  • Client has mild to moderate dementia (MMSE score 10-24, DSM IV criteria for dementia)
  • Client lives at home
  • Client has an informal caregiver who takes care of the client at least twice a week
  • Client is in a severe stage of dementia
  • Client has a depression (GDS (version 30) \>12)
  • Client has severe behavioral or psychological symptoms in dementia (BPSD)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 17114212BACKGROUND
  • Graff MJ, Adang EM, Vernooij-Dassen MJ, Dekker J, Jonsson L, Thijssen M, Hoefnagels WH, Rikkert MG. Community occupational therapy for older patients with dementia and their care givers: cost effectiveness study. BMJ. 2008 Jan 19;336(7636):134-8. doi: 10.1136/bmj.39408.481898.BE. Epub 2008 Jan 2.

    PMID: 18171718BACKGROUND
  • Voigt-Radloff S, Graff M, Leonhart R, Schornstein K, Vernooij-Dassen M, Olde-Rikkert M, Huell M. WHEDA study: effectiveness of occupational therapy at home for older people with dementia and their caregivers--the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres. BMC Geriatr. 2009 Oct 2;9:44. doi: 10.1186/1471-2318-9-44.

    PMID: 19799779BACKGROUND
  • Graff MJ, Vernooij-Dassen MJ, Thijssen M, Dekker J, Hoefnagels WH, Olderikkert MG. Effects of community occupational therapy on quality of life, mood, and health status in dementia patients and their caregivers: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2007 Sep;62(9):1002-9. doi: 10.1093/gerona/62.9.1002.

    PMID: 17895439BACKGROUND
  • Dopp CM, Graff MJ, Teerenstra S, Olde Rikkert MG, Nijhuis-van der Sanden MW, Vernooij-Dassen MJ. Effectiveness of a training package for implementing a community-based occupational therapy program in dementia: a cluster randomized controlled trial. Clin Rehabil. 2015 Oct;29(10):974-86. doi: 10.1177/0269215514564699. Epub 2014 Dec 28.

  • Dopp CM, Graff MJ, Teerenstra S, Nijhuis-van der Sanden MW, Olde Rikkert MG, Vernooij-Dassen MJ. Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial. BMC Fam Pract. 2013 May 30;14:70. doi: 10.1186/1471-2296-14-70.

  • Dopp CM, Graff MJ, Teerenstra S, Adang E, Nijhuis-van der Sanden RW, Olderikkert MG, Vernooij-Dassen MJ. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial. BMC Geriatr. 2011 Mar 30;11:13. doi: 10.1186/1471-2318-11-13.

MeSH Terms

Conditions

DementiaPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Myrra Vernooij-Dassen, PhD

    Radboud University Medical Center

    STUDY CHAIR
  • Maud Graff, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 5, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 21, 2010

Record last verified: 2010-03

Locations