A Support Program for Carers of Persons With Dementia

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Support Program for Carers of Persons With Dementia - a 24 Months RCT

Conditions
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Dementia, Depression

Intervention / Treatment
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* Behavioral: A multidimensional support program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group, ordinary support<br>Home care as usual. | |
| Experimental: A multidimensjonalt support program<br>•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups. | Behavioral: A multidimensional support program<br>* Counseling, education and problem-solving in support group, ad hoc counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after 12 months | 
| Change in stress among carers | Relatives Stress Scale(RSS) will be used | after 12 months | 
| Neuropsychiatric Inventory (NPI) |  | after 12 months | 
| Quality of life among people with dementia and carers | The Quality of life in Alzheimer's disease (QOL-AD) | after 12 months | 
| Measures function in activities of daily living | Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL) | after 12 months | 
| measure expressed emotion | Using Felt Expressed Emotion Rating Scale (FEERS) | after 12 months | 
| Locus of control among carers |  | after 12 months | 
| Mini mental status (MMSE) |  | after 12 months | 
| 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. | after 24 months | 
| Resource Utilisation in Dementia |  | after 24 months | 
| Change in stress among carers(RSS) |  | after 24 months | 
| Neuropsychiatric Inventory (NPI) |  | after 24 months | 
| Quality of life among people with dementia and carers(QOL-AD) |  | after 24 months | 
| Measures function in activities of daily living |  | after 24 months | 
| Locus of control among carers |  | after 24 months | 
| measure expressed emotion |  | after 24 months | 
| Mini mental status (MMSE) |  | after 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Depression, Burden of care, Psychosocial intervention, Family home care