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 quality of life of patients and informal caregivers (spouse, relative), as compared with usual care?

Condition	Intervention
Dementia, Alzheimer Disease, Lewy-Body, Vascular dementia	Behavior: Diagnosis of carers'''' problems  Behavior: Professional service: treatment of problems by counseling or practical support

Further Study Details: 

Primary Outcomes: Patients´ admissions to nursing homes or residential homes after one year follow up period. This outcome is the most important input for the estimation of costs differences between intervention and controls.
Secondary Outcomes: 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
Expected Total Enrollment:  520

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 chosing 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 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 assessed by the NPI-Q and the QOL-AD-Scale. The power analysis is based on our previous study in which 14% of the patients in the intervention group and 28% in the control group were institutionalized. The numbers of pairs of patients and informal caregivers needed is based on two-sided testing with an alpha of 5%, a power of 80% and Intra Class Correlation 0.05; the numbers are 260 for both the intervention and the control group. 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 result in a net benefit.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• patients and caregivers’ not mastering the Dutch language

Please refer to this study by ClinicalTrials.gov identifier  NCT00147693

Anouk A Spijker, MA      31-24-3610138    a.spijker@kwazo.umcn.nl
Myrra M Vernooij-Dassen, PhD      31-24-3615300    M.Vernooy-Dassen@VOHA.umcn.nl

Netherlands
      Radboud University Nijmegen Medical Centre, Nijmegen,  Netherlands; Recruiting

Study chairs or principal investigators

Myrra M Vernooij-Dassen, PhD,  Principal Investigator,  Coordinator Alzheimer Centre UMC Nijmegen   

Study ID Numbers:  SCAD; ZonMw grant no 945-04-152
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147693
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13