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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Netherlands1 site
  • Radboud University Nijmegen Medical Centre

    Nijmegen

Other trials in Netherlands

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.

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.

  1. 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)
  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.

  1. First posted7 Sep 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionFeb 2006
  4. Study completionFeb 2006

Resources

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)
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

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.

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