Implementation and Evaluation of the COTiD Program in the Netherlands
1 other identifier
interventional
180
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2009
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 21, 2010
March 1, 2010
2.2 years
May 3, 2010
May 20, 2010
Conditions
Keywords
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 COMPARATOR3-day post-graduate course on the use of the COTiD program in clinical practice
Combined implementation strategy
EXPERIMENTALThe 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.
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.
Eligibility Criteria
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
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: 17114212BACKGROUNDGraff 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: 18171718BACKGROUNDVoigt-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: 19799779BACKGROUNDGraff 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: 17895439BACKGROUNDDopp 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.
PMID: 25547113DERIVEDDopp 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.
PMID: 23718565DERIVEDDopp 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.
PMID: 21450063DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Myrra Vernooij-Dassen, PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Maud Graff, PhD
Radboud University Medical Center
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