DementiaNCT01117285
Implementation and Evaluation of the COTiD Program in the Netherlands
A study testing 3-day post-graduate course and Combined implementation strategy in people with Dementia, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- 3-day post-graduate course and Combined implementation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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 is in a severe stage of dementia
Show all 10Show fewer
- Client has a depression (GDS (version 30) >12)
- Client has severe behavioral or psychological symptoms in dementia (BPSD)
- Client has a severe illness at the time of inclusion
- The caregiver is not able to participate in the OT treatment (e.g. due to illness).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre, Scientific Institute for Quality of Healthcare (IQ healthcare) (and 45 Dutch organisation)
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program
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.
Read the detailed description
Dementia is associated with a major decrease in quality of life of clients and their caregivers and a major driver of costs in health care. Recently, evidence was found for the effectiveness and cost-effectiveness of a community-based occupational therapy (OT) intervention for older adults with dementia and their caregivers (COTiD program). This intervention resulted in significant improvements in both clients' and caregivers' daily functioning, quality of life, mood and health status. In addition, caregivers experienced an increased sense of competence.
Currently occupational therapists (OTs) are trained in using the program during a 3-day course. In a pilot implementation study it was found that this course was not effective enough as only 20% of the OTs actually used the COTiD program in practice because of a lack of implementation skills, feedback and organisational barriers. In order to increase the use of this program and increase the quality of care a new implementation strategy is developed. This combined implementation strategy provides the OTs with two implementation training days, coaching on the job, regional meetings, discussion platform, web-based registration system and newsletters. In addition physicians and managers are provided with extra information on the COTiD program.
The current study is designed primarily to evaluate the following research questions:
- What is the difference in adherence to the community OT guideline in dementia between OTs receiving the combined implementation strategy and OTs receiving the educational strategy?
- What is the difference in community OT use(referral rate + actual provision of OT) between clusters provided with the combined implementation strategy and clusters provided with the educational strategy?
- What is the difference in cost-effectiveness between the combined implementation strategy and the educational strategy with regard to adherence of OTs to the community OT guideline?
In addition the effect of the implementation strategies on patient and caregiver outcomes will also be measured.
- Conditions
- Dementia
- Being tested
- 3-day post-graduate course, Combined implementation strategy
- Keywords
- Occupational Therapy, Evidence-Based Practice, Continuing Education, utilization, Guideline, Dementia, Guideline implementation
- Medical subject headings
- Dementia, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-day post-graduate courseOther
Also called educational strategy
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.
Combined implementation strategyOther
Also called implementation training
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-day post-graduate course | Active comparator | 3-day post-graduate course on the use of the COTiD program in clinical practice Receives: Other: 3-day post-graduate course |
| Combined implementation strategy | Experimental | The combined implementation strategy Receives: Other: Combined implementation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: October 2009 - December 2011
Secondary outcomes (2)
Knowledge of the healthcare professionals about the COTiD program
measured using a multiple choice knowledge test on the most important aspects of the COTiD program.
Measured: one year (baseline, T1, and T2)
COTiD program treatment outcome on client and caregiver level
The following outcomes are evaluated:
- Clients'processing skills (Assessment of Motor and Process Skills)
- Need for assistance in daily activities (Interview of Deterioration of Daily Activities in Dementia)
- Caregivers Sense of Competence (Sense of Competense Questionnaire)
- Client and caregiver quality of life (EQ5D and Dementia Quality of Life Scale)
- Client and caregiver self-perceived performance and satisfaction (Canadian Occupational Performance Measure)
Measured: one year (baseline, T1, and T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- HAN University of Applied Sciences
- Investigators
- Myrra Vernooij-Dassen, PhD, Study chair, Radboud University Medical CenterMaud Graff, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117285
- Sponsor's protocol ID
- 80-82315-98-090010
- Status last verified
- Mar 2010
- First submitted
- 3 May 2010
- Last updated
- 21 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17114212Graff 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.
PubMed 18171718Voigt-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.
PubMed 19799779Graff 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.
PubMed 17895439Dopp 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.
PubMed 25547113Dopp 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.
PubMed 23718565Dopp 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.
PubMed 21450063
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of an Effective Community Occupational Therapy in Dementia (COTiD) Program
- ClinicalTrials.gov ID
- NCT01117285
- Acronym / sponsor ID
- 80-82315-98-090010
- Conditions
- Dementia
- Keywords
- Occupational Therapy, Evidence-Based Practice, Continuing Education, utilization, Guideline, Dementia, Guideline implementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- HAN University of Applied Sciences
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dementia is associated with a major decrease in quality of life of clients and their caregivers and a major driver of costs in health care. Recently, evidence was found for the effectiveness and cost-effectiveness of a community-based occupational therapy (OT) intervention for older adults with dementia and their caregivers (COTiD program). This intervention resulted in significant improvements in both clients' and caregivers' daily functioning, quality of life, mood and health status. In addition, caregivers experienced an increased sense of competence.
Currently occupational therapists (OTs) are trained in using the program during a 3-day course. In a pilot implementation study it was found that this course was not effective enough as only 20% of the OTs actually used the COTiD program in practice because of a lack of implementation skills, feedback and organisational barriers. In order to increase the use of this program and increase the quality of care a new implementation strategy is developed. This combined implementation strategy provides the OTs with two implementation training days, coaching on the job, regional meetings, discussion platform, web-based registration system and newsletters. In addition physicians and managers are provided with extra information on the COTiD program.
The current study is designed primarily to evaluate the following research questions:
- What is the difference in adherence to the community OT guideline in dementia between OTs receiving the combined implementation strategy and OTs receiving the educational strategy?
- What is the difference in community OT use(referral rate + actual provision of OT) between clusters provided with the combined implementation strategy and clusters provided with the educational strategy?
- What is the difference in cost-effectiveness between the combined implementation strategy and the educational strategy with regard to adherence of OTs to the community OT guideline?
In addition the effect of the implementation strategies on patient and caregiver outcomes will also be measured.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-day post-graduate course | Active comparator | Other: 3-day post-graduate course3-day post-graduate course on the use of the COTiD program in clinical practice |
| Combined implementation strategy | Experimental | Other: Combined implementation strategyThe combined implementation strategy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Client has mild to moderate dementia (MMSE score 10-24, DSM IV criteria for dementia)
- Client lives at home
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-day post-graduate courseAlso: educational strategyA 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. | Other | 3-day post-graduate course |
| Combined implementation strategyAlso: implementation trainingThe 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. | Other | Combined implementation strategy |
Primary outcome
Adherence of occupational therapists to the COTiD program
Time frame: one year (baseline, T1, and T2)
Adherence is measured using vignettes. Vignettes are realistic case descriptions about which occupational therapists are asked to answer open ended questions.
Community occupational therapy use according to the COTiD program
Time frame: one year
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.
Costs of the implementation strategies
Time frame: October 2009 - December 2011
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
2 secondary outcomes
Knowledge of the healthcare professionals about the COTiD program
Time frame: one year (baseline, T1, and T2)
COTiD program treatment outcome on client and caregiver level
Time frame: one year (baseline, T1, and T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2010.
- Background: PubMed 17114212Graff 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.
- Background: PubMed 18171718Graff 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.
- Background: PubMed 19799779Voigt-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.
- Background: PubMed 17895439Graff 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.
- Derived from this study: PubMed 25547113Dopp 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.
- Derived from this study: PubMed 23718565Dopp 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.
- Derived from this study: PubMed 21450063Dopp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myrra Vernooij-Dassen, PhD study chair
Radboud University Medical Center
Maud Graff, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-day post-graduate course and Combined implementation strategy in people with Dementia, run by ZonMw: The Netherlands Organisation for Health Research and Development at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of occupational therapists to the COTiD program (time frame: one year (baseline, T1, and T2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117285, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2010.