A Support Program for Carers of Persons With Dementia (DIF2)
Primary Purpose
Dementia, Depression
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
A multidimensional support program
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Depression, Burden of care, Psychosocial intervention, Family home care
Eligibility Criteria
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
Sites / Locations
- Norwegian Centre for Ageing and Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group, ordinary support
A multidimensjonalt support program
Arm Description
Home care as usual.
•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.
Outcomes
Primary Outcome Measures
Differences in level of depression between groups
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.
Secondary Outcome Measures
Resource Utilisation in Dementia
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.
Change in stress among carers
Relatives Stress Scale(RSS) will be used
Neuropsychiatric Inventory (NPI)
Quality of life among people with dementia and carers
The Quality of life in Alzheimer's disease (QOL-AD)
Measures function in activities of daily living
Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)
measure expressed emotion
Using Felt Expressed Emotion Rating Scale (FEERS)
Locus of control among carers
Mini mental status (MMSE)
Differences in level of depression between groups
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.
Resource Utilisation in Dementia
Change in stress among carers(RSS)
Neuropsychiatric Inventory (NPI)
Quality of life among people with dementia and carers(QOL-AD)
Measures function in activities of daily living
Locus of control among carers
measure expressed emotion
Mini mental status (MMSE)
Full Information
NCT ID
NCT01287767
First Posted
January 26, 2011
Last Updated
October 6, 2015
Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway, Kavli Research Center for Ageing and Dementia
1. Study Identification
Unique Protocol Identification Number
NCT01287767
Brief Title
A Support Program for Carers of Persons With Dementia
Acronym
DIF2
Official Title
A Support Program for Carers of Persons With Dementia - a 24 Months RCT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway, Kavli Research Center for Ageing and Dementia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dementia is one of the most common and devastating diseases in the elderly, it leads to helplessness, no cure exists and therefore care is necessary to provide. The care is associated with a great burden for the family carers and expensive for the society when residential care is required. The purpose of this study is to improve knowledge on how to provide better care for both the patients and their family carers, the investigators want to carry out a controlled trial using a rather cheap form of intervention, a multidimensional support program - an 18 months randomized controlled intervention study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Depression
Keywords
Dementia, Depression, Burden of care, Psychosocial intervention, Family home care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group, ordinary support
Arm Type
No Intervention
Arm Description
Home care as usual.
Arm Title
A multidimensjonalt support program
Arm Type
Experimental
Arm Description
•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.
Intervention Type
Behavioral
Intervention Name(s)
A multidimensional support program
Intervention Description
Counseling, education and problem-solving in support group, ad hoc counseling
Primary Outcome Measure Information:
Title
Differences in level of depression between groups
Description
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.
Time Frame
After 12 months
Secondary Outcome Measure Information:
Title
Resource Utilisation in Dementia
Description
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.
Time Frame
after 12 months
Title
Change in stress among carers
Description
Relatives Stress Scale(RSS) will be used
Time Frame
after 12 months
Title
Neuropsychiatric Inventory (NPI)
Time Frame
after 12 months
Title
Quality of life among people with dementia and carers
Description
The Quality of life in Alzheimer's disease (QOL-AD)
Time Frame
after 12 months
Title
Measures function in activities of daily living
Description
Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)
Time Frame
after 12 months
Title
measure expressed emotion
Description
Using Felt Expressed Emotion Rating Scale (FEERS)
Time Frame
after 12 months
Title
Locus of control among carers
Time Frame
after 12 months
Title
Mini mental status (MMSE)
Time Frame
after 12 months
Title
Differences in level of depression between groups
Description
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.
Time Frame
after 24 months
Title
Resource Utilisation in Dementia
Time Frame
after 24 months
Title
Change in stress among carers(RSS)
Time Frame
after 24 months
Title
Neuropsychiatric Inventory (NPI)
Time Frame
after 24 months
Title
Quality of life among people with dementia and carers(QOL-AD)
Time Frame
after 24 months
Title
Measures function in activities of daily living
Time Frame
after 24 months
Title
Locus of control among carers
Time Frame
after 24 months
Title
measure expressed emotion
Time Frame
after 24 months
Title
Mini mental status (MMSE)
Time Frame
after 24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Engedal, M.D.PhD
Organizational Affiliation
Norwegian Centre for Ageing and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian Centre for Ageing and Health
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31651321
Citation
Bjorge H, Kvaal K, Ulstein I. The effect of psychosocial support on caregivers' perceived criticism and emotional over-involvement of persons with dementia: an assessor-blinded randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):744. doi: 10.1186/s12913-019-4551-x.
Results Reference
derived
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A Support Program for Carers of Persons With Dementia
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