Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147693
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2005-09-06
Brief Title:
Systematic Care for Informal Caregivers of Dementia Patients An Efficient Approach
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Systematic Care for Informal Caregivers of Dementia Patients An Efficient Approach
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients and informal caregivers spouse relative as compared with usual care
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 caregivers 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 19931995 To detect a 50 reduction in institutionalization rates with 80 power at the two sided significance level of 005 132 patient-caregiver dyads would be needed for each of the intervention and control arm We inflated this sample size by a design effect of 115 to 152 dyads per trial arm to allow for correlation of dyads within the same cluster ie professional assuming an average cluster size of four and an intracluster correlation coefficient of 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZonMw grant no 945-04-152 | None | None | None |