DementiaNCT00459784
Implementation Study of Dementia Guidelines in Primary Care
A study testing Dementia Training Program in people with Dementia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia Training Program
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2006to Mar 2008
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- GP and practice or district nurse must participate as a duo
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Geriatrie 925, Postbus 9101
Nijmegen, 6500 HB
Marieke Perry, MD, 0031-24-3610142, m.perry@ger.umcn.nl
Marieke Perry, MD
About this study
Official title: How to Reach Evidence Based Practice in Diagnostic Assessment and Management of Dementia by General Practitioners and Primary Care Nurses? The Effectiveness of an EASYcare Based Educational Program.
The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines
Read the detailed description
Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed in developed countries. In several countries educational interventions were developed to improve dementia diagnosis and management in primary care. Some of these interventions were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed a Dementia Training Program (DTP) aimed at stimulating collaboration in dementia primary care. We expect it to increase the number of cognitive assessments and dementia diagnoses, as well as to improve attitudes and knowledge of GPs and nurses.
Methods/Design The DTP is a complex educational intervention and consists of 2 workshops, a coaching program, and case-based consultations either face-to-face or by phone or e-mail, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics and management. 100 duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in an assessor blinded cluster-randomised controlled trial. Primary outcomes are the number of cognitive assessments and dementia diagnosis in a period of 9 months, starting after workshop participation of the duos. Secondary outcomes are measured on GP and nurse level: rate of adherence to national guidelines for dementia diagnosis, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical dossiers, self registration forms and questionnaires. Statistical analysis will be performed by using MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and the causal relations between the rate of success of the intervention components and the outcomes.
- Conditions
- Dementia
- Being tested
- Dementia Training Program
- Keywords
- Improvement, Dementia early diagnosis, Dementia management, Primary care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Training ProgramProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dementia diagnoses and cognitive assessments during 9 months
Secondary outcomes (1)
Accuracy tot dementia guidelines, GP and nurse knowlegde and attitude and competence regarding dementia. Patient satisfaction, caregiver burden and satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startNov 2006
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- County of Gelderland, ZonMw: The Netherlands Organisation for Health Research and Development, Health Valley, Netherlands, Stichting Thuiszorgorganisatie Midden-Gelderland, Stichting Thuiszorgorganisatie Mawe Rivierenland, Sensire Winterwijk, Kruiswerk West Veluwe
- Investigators
- Marcel Olde Rikkert, Prof, MD, Study director, Alheimer Centre Nijmegen, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459784
- Sponsor's protocol ID
- EASYcareGIDS study
- Status last verified
- Apr 2007
- First submitted
- 12 Apr 2007
- Last updated
- 13 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Perry M, Draskovic I, van Achterberg T, Borm GF, van Eijken MI, Lucassen P, Vernooij-Dassen MJ, Olde Rikkert MG. Can an EASYcare based dementia training programme improve diagnostic assessment and management of dementia by general practitioners and primary care nurses? The design of a randomised controlled trial. BMC Health Serv Res. 2008 Apr 2;8:71. doi: 10.1186/1472-6963-8-71.
PubMed 18384675
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Reach Evidence Based Practice in Diagnostic Assessment and Management of Dementia by General Practitioners and Primary Care Nurses? The Effectiveness of an EASYcare Based Educational Program.
- ClinicalTrials.gov ID
- NCT00459784
- Acronym / sponsor ID
- EASYcareGIDS study
- Conditions
- Dementia
- Keywords
- Improvement, Dementia early diagnosis, Dementia management, Primary care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- County of Gelderland, ZonMw: The Netherlands Organisation for Health Research and Development, Health Valley, Netherlands, Stichting Thuiszorgorganisatie Midden-Gelderland, Stichting Thuiszorgorganisatie Mawe Rivierenland, Sensire Winterwijk, Kruiswerk West Veluwe
- Study start
- Nov 2006
- Study completion
- Mar 2008 (estimated)
- First posted
- 13 Apr 2007 (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 purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines
Detailed description
Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed in developed countries. In several countries educational interventions were developed to improve dementia diagnosis and management in primary care. Some of these interventions were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed a Dementia Training Program (DTP) aimed at stimulating collaboration in dementia primary care. We expect it to increase the number of cognitive assessments and dementia diagnoses, as well as to improve attitudes and knowledge of GPs and nurses.
Methods/Design The DTP is a complex educational intervention and consists of 2 workshops, a coaching program, and case-based consultations either face-to-face or by phone or e-mail, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics and management. 100 duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in an assessor blinded cluster-randomised controlled trial. Primary outcomes are the number of cognitive assessments and dementia diagnosis in a period of 9 months, starting after workshop participation of the duos. Secondary outcomes are measured on GP and nurse level: rate of adherence to national guidelines for dementia diagnosis, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical dossiers, self registration forms and questionnaires. Statistical analysis will be performed by using MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and the causal relations between the rate of success of the intervention components and the outcomes.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GP and practice or district nurse must participate as a duo
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Dementia Training Program | Procedure or surgery | – |
Primary outcome
Number of dementia diagnoses and cognitive assessments during 9 months
1 secondary outcome
Accuracy tot dementia guidelines, GP and nurse knowlegde and attitude and competence regarding dementia. Patient satisfaction, caregiver burden and satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2007.
- Derived from this study: PubMed 18384675Perry M, Draskovic I, van Achterberg T, Borm GF, van Eijken MI, Lucassen P, Vernooij-Dassen MJ, Olde Rikkert MG. Can an EASYcare based dementia training programme improve diagnostic assessment and management of dementia by general practitioners and primary care nurses? The design of a randomised controlled trial. BMC Health Serv Res. 2008 Apr 2;8:71. doi: 10.1186/1472-6963-8-71.
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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.
Marcel Olde Rikkert, Prof, MD study director
Alheimer Centre Nijmegen, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Training Program in people with Dementia, run by Radboud University Medical Center 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 1 inclusion and 1 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 13 Apr 2007. 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?
Contact Marieke Perry, MD (0031-24-3610142, m.perry@ger.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dementia diagnoses and cognitive assessments during 9 months. 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 NCT00459784, which also lists 1 linked publication.
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 13 Apr 2007.