- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287767
A Support Program for Carers of Persons With Dementia (DIF2)
A Support Program for Carers of Persons With Dementia - a 24 Months RCT
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The 230 dyads of families, patients and carers, will be recruited from 18 municipalities, 18 from each municipality with at least 15 000 inhabitants. Only home dwelling patients and carers with at least weekly face-to face contact with the patient will be included. The patients will be recruited both from memory clinics, outpatients clinics in geriatric medicine and old age psychiatry and from home nurse districts. The patients should have a diagnosis of dementia according to ICD-10 criteria, have a score on Mini Mental State Examination of at least 15 points and have capacity to give informant consent to participation in the study. The carers should score at least five on the Relatives' Stress Scale.
115 family, control group, will receive care 'as usual' in the municipalities. The 115 family intervention group will have a duration of 18 months consisting individual counselling, education about dementia, problem-solving groups and ad-hoc counselling when needed. Effects will be measured at three levels, at patient level, at carer level and at societal level. Measurements will take place at baseline, after three, six, 12 and 18 months. At patient level, the Cornell scale will be used as the primary outcome. At carer's level, the primary outcome is the Relatives' Stress Scale. For the outcome on the social level Resource Utilisation in Dementia will be used.
The carers will be contacted every year up till five years after the intervention ended to give information about their own physical and psychological health and the patient's use of formal help such as day care centre, respite care and permanent nursing home placement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0407
- Norwegian Centre for Ageing and Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Home dwelling patients and carers with at least weekly face-to face contact with the patients
- The patients should have a diagnosis of dementia according to ISD-10 criteria
- A Mini Mental State Examination (MMSE)og at least 15 point.
- Have capacity to give informant consent to participation in the study
- The carers should score at least five on the Relatives'Stress Scale(RSS)
Exclusion Criteria:
- Result from the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control group, ordinary support
Home care as usual.
|
|
EXPERIMENTAL: A multidimensjonalt support program
•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.
|
Counseling, education and problem-solving in support group, ad hoc counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in level of depression between groups
Time Frame: After 12 months
|
Cornell scala for depression will be used to measure depression among the person with dementia and Geriatric Depression Scale (GDS) will be used for the carer.
|
After 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resource Utilisation in Dementia
Time Frame: after 12 months
|
Resource Utilisation in Dementia (RUD Lite) instrument (Wimo, 1998) which contains questions concerning use of community care services, type of accommodation, the employment status of the patient and primary caregiver, medical and informal care.
|
after 12 months
|
Change in stress among carers
Time Frame: after 12 months
|
Relatives Stress Scale(RSS) will be used
|
after 12 months
|
Neuropsychiatric Inventory (NPI)
Time Frame: after 12 months
|
after 12 months
|
|
Quality of life among people with dementia and carers
Time Frame: after 12 months
|
The Quality of life in Alzheimer's disease (QOL-AD)
|
after 12 months
|
Measures function in activities of daily living
Time Frame: after 12 months
|
Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)
|
after 12 months
|
measure expressed emotion
Time Frame: after 12 months
|
Using Felt Expressed Emotion Rating Scale (FEERS)
|
after 12 months
|
Locus of control among carers
Time Frame: after 12 months
|
after 12 months
|
|
Mini mental status (MMSE)
Time Frame: after 12 months
|
after 12 months
|
|
Differences in level of depression between groups
Time Frame: after 24 months
|
Cornell scala for depression will be used to measure depression among the person with dementia and Geriatric Depression Scale (GDS) will be used for the carer.
|
after 24 months
|
Resource Utilisation in Dementia
Time Frame: after 24 months
|
after 24 months
|
|
Change in stress among carers(RSS)
Time Frame: after 24 months
|
after 24 months
|
|
Neuropsychiatric Inventory (NPI)
Time Frame: after 24 months
|
after 24 months
|
|
Quality of life among people with dementia and carers(QOL-AD)
Time Frame: after 24 months
|
after 24 months
|
|
Measures function in activities of daily living
Time Frame: after 24 months
|
after 24 months
|
|
Locus of control among carers
Time Frame: after 24 months
|
after 24 months
|
|
measure expressed emotion
Time Frame: after 24 months
|
after 24 months
|
|
Mini mental status (MMSE)
Time Frame: after 24 months
|
after 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Knut Engedal, M.D.PhD, Norwegian Centre for Ageing and Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FI09
- NFR189449 (OTHER: The Research Counsil of Norway)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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