Dementia, VascularNCT00147693
Systematic Care for Informal Caregivers of Dementia Patients: An Efficient Approach?
A study testing Diagnosis of caregivers' problems and Professional service: treatment of problems by counseling or practical support in people with Dementia, Vascular and Dementia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The objective is to ascertain the potential efficiency of a systematic care programme for caregivers of dementia patients. The research questions are: What are the costs and benefits of the Systematic Care Programme - Dementia (SCP-Dementia), as compared with usual care? What are the effects on the quality of life of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Vascular, Dementia, Alzheimer Disease
- What is being tested?
- Diagnosis of caregivers' problems and Professional service: treatment of problems by counseling or practical support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 304 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2005to Feb 2006
- 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
- Pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time and treated by the professionals participating in the study
Who cannot join
- Patients and caregivers not mastering the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to ascertain the potential efficiency of a systematic care programme for caregivers of dementia patients. The research questions are:
- What are the costs and benefits of the Systematic Care Programme - Dementia (SCP-Dementia), as compared with usual care?
- What are the effects on the quality of life of patients and informal caregivers (spouse, relative), as compared with usual care?
Read the detailed description
A major challenge for future health care is the care for dementia patients and their informal caregivers. In usual care, the problems of caregivers often remain invisible until a crisis occurs. This inhibition is partly the result of informal caregivers paying scant attention to their own problems. Another reason is that professionals may not know how to support informal caregivers pro-actively (Van Hout et al., 2000). Therefore the family support programme (Bengtson, 1985: Vernooij et al., 2000) has been transformed into a Systematic Care Programme (SCP-Dementia). The reasons for choosing and studying the efficiency of this programme are the potential to diagnose and treat problems systematically, to cover a wide range of individual problems, its flexibility in connecting interventions to these problems, its suitability for pro-activity and the positive effects of the programme found in our previous study (Vernooij et al., 2000). To study its efficiency a cluster randomised controlled trial design will be used. Randomisation will take place in each of three participating regions. Professionals in the ambulatory mental health care services (psychologists and social psychiatric nurses) will be randomly assigned to either the intervention group or the control group before the recruitment of patients and informal caregivers. The study population consists of pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time. The intervention is the training in SCP-Dementia and its subsequent use. SCP-Dementia consists of an assessment of the caregiver's sense of competence and suggestions on how to deal with deficiencies in competence. The follow-up period is one year. The primary outcome is patients´ admissions to nursing homes or residential homes. The secondary outcome is quality of life. Caregivers´ quality of life is assessed by sense of competence (SCQ), depression (CES-D) and physical quality of life (EuroQol). Patients´ quality of life by behavioral problems is assessed by the NPI-Q and the QOL-AD-Scale. The difference in proposed effect was based on previous research in which 14% of the patients in the intervention group and 28% in the control group were institutionalized (Vernooij-Dassen, 1993;1995). To detect a 50% reduction in institutionalization rates with 80% power at the two sided significance level of 0.05, 132 patient-caregiver dyads would be needed for each of the intervention and control arm. We inflated this sample size by a design effect of 1.15 to 152 dyads per trial arm to allow for correlation of dyads within the same cluster (i.e. professional), assuming an average cluster size of four and an intracluster correlation coefficient of 0.05. Assuming a 25% dropout rate of patient-caregiver dyads, the study needed an final enrolment of 190 dyads in each trial arm. The economic evaluation is a cost-effectiveness analysis regarding a societal perspective. In the economic evaluation both costs and effects will be monetarized and consequently will result in a net benefit.
- Conditions
- Dementia, Vascular, Dementia, Alzheimer Disease, Lewy Body Disease
- Being tested
- Diagnosis of caregivers' problems, Professional service: treatment of problems by counseling or practical support
- Keywords
- Dementia, Alzheimer Disease, Lewy-Body, Cost*, Community (dwelling), Caregiver(s), Institutionalization, Quality of life, Randomized Control Trail, Vascular dementia
- Medical subject headings
- Dementia, Vascular, Dementia, Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of caregivers' problemsBehavioural
Professional service: treatment of problems by counseling or practical supportBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients admissions to nursing homes or residential homes. This outcome is the most important input for the estimation of cost differences between the intervention group and controls.
Measured: after one year follow-up period
Secondary outcomes (1)
Secondary outcome for cost estimation is patient and caregiver related costs estimated by "Resource Utilisation in Dementia" (RUD), including time spent on caregiving, use of health care services by caregivers and patients and additional productivity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionFeb 2006
- Study completionFeb 2006
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 Dementia, VascularStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Myrra M Vernooij-Dassen, PhD, Principal investigator, Coordinator Alzheimer Centre UMC Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147693
- Sponsor's protocol ID
- SCAD
- Other IDs
- ZonMw grant no 945-04-152
- Status last verified
- Sep 2008
- First submitted
- 6 Sep 2005
- Last updated
- 1 Oct 2008
- Results posted
- No
Publications
Spijker A, Verhey F, Graff M, Grol R, Adang E, Wollersheim H, Vernooij-Dassen M. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial. BMC Geriatr. 2009 Jun 7;9:21. doi: 10.1186/1471-2318-9-21.
PubMed 19500421
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Care for Informal Caregivers of Dementia Patients: An Efficient Approach?
- ClinicalTrials.gov ID
- NCT00147693
- Acronym / sponsor ID
- SCAD
- Conditions
- Dementia, Vascular, Dementia, Alzheimer Disease, Lewy Body Disease
- Keywords
- Dementia, Alzheimer Disease, Lewy-Body, Cost*, Community (dwelling), Caregiver(s), Institutionalization, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jun 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Sep 2005 (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 objective is to ascertain the potential efficiency of a systematic care programme for caregivers of dementia patients. The research questions are:
- What are the costs and benefits of the Systematic Care Programme - Dementia (SCP-Dementia), as compared with usual care?
- What are the effects on the quality of life of patients and informal caregivers (spouse, relative), as compared with usual care?
Detailed description
A major challenge for future health care is the care for dementia patients and their informal caregivers. In usual care, the problems of caregivers often remain invisible until a crisis occurs. This inhibition is partly the result of informal caregivers paying scant attention to their own problems. Another reason is that professionals may not know how to support informal caregivers pro-actively (Van Hout et al., 2000). Therefore the family support programme (Bengtson, 1985: Vernooij et al., 2000) has been transformed into a Systematic Care Programme (SCP-Dementia). The reasons for choosing and studying the efficiency of this programme are the potential to diagnose and treat problems systematically, to cover a wide range of individual problems, its flexibility in connecting interventions to these problems, its suitability for pro-activity and the positive effects of the programme found in our previous study (Vernooij et al., 2000). To study its efficiency a cluster randomised controlled trial design will be used. Randomisation will take place in each of three participating regions. Professionals in the ambulatory mental health care services (psychologists and social psychiatric nurses) will be randomly assigned to either the intervention group or the control group before the recruitment of patients and informal caregivers. The study population consists of pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time. The intervention is the training in SCP-Dementia and its subsequent use. SCP-Dementia consists of an assessment of the caregiver's sense of competence and suggestions on how to deal with deficiencies in competence. The follow-up period is one year. The primary outcome is patients´ admissions to nursing homes or residential homes. The secondary outcome is quality of life. Caregivers´ quality of life is assessed by sense of competence (SCQ), depression (CES-D) and physical quality of life (EuroQol). Patients´ quality of life by behavioral problems is assessed by the NPI-Q and the QOL-AD-Scale. The difference in proposed effect was based on previous research in which 14% of the patients in the intervention group and 28% in the control group were institutionalized (Vernooij-Dassen, 1993;1995). To detect a 50% reduction in institutionalization rates with 80% power at the two sided significance level of 0.05, 132 patient-caregiver dyads would be needed for each of the intervention and control arm. We inflated this sample size by a design effect of 1.15 to 152 dyads per trial arm to allow for correlation of dyads within the same cluster (i.e. professional), assuming an average cluster size of four and an intracluster correlation coefficient of 0.05. Assuming a 25% dropout rate of patient-caregiver dyads, the study needed an final enrolment of 190 dyads in each trial arm. The economic evaluation is a cost-effectiveness analysis regarding a societal perspective. In the economic evaluation both costs and effects will be monetarized and consequently will result in a net benefit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time and treated by the professionals participating in the study
Key exclusion criteria (1 listed)
- Patients and caregivers not mastering the Dutch language
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 |
|---|---|---|
| Diagnosis of caregivers' problems | Behavioural | – |
| Professional service: treatment of problems by counseling or practical support | Behavioural | – |
Primary outcome
Patients admissions to nursing homes or residential homes. This outcome is the most important input for the estimation of cost differences between the intervention group and controls.
Time frame: after one year follow-up period
1 secondary outcome
Secondary outcome for cost estimation is patient and caregiver related costs estimated by "Resource Utilisation in Dementia" (RUD), including time spent on caregiving, use of health care services by caregivers and patients and additional productivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
- Derived from this study: PubMed 19500421Spijker A, Verhey F, Graff M, Grol R, Adang E, Wollersheim H, Vernooij-Dassen M. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial. BMC Geriatr. 2009 Jun 7;9:21. doi: 10.1186/1471-2318-9-21.
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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 M Vernooij-Dassen, PhD principal investigator
Coordinator Alzheimer Centre UMC Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis of caregivers' problems and Professional service: treatment of problems by counseling or practical support in people with Dementia, Vascular and 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: finished, as of the sponsor's last update on 1 Oct 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients admissions to nursing homes or residential homes. This outcome is the most important input for the estimation of cost differences between the intervention group and controls. (time frame: after one year follow-up period). 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 NCT00147693, 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 1 Oct 2008; AzTrials last refreshed its copy on 8 Nov 2026.