Clinical trial NCT01287767: A Support Program for Carers of Persons With Dementia
Official title: A Support Program for Carers of Persons With Dementia - a 24 Months RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Depression
Keywords: Dementia
Depression
Burden of care
Psychosocial intervention
Family home care
Lead sponsor: Norwegian Centre for Ageing and Health
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Kavli Research Center for Ageing and Dementia
First posted: 2011-02-01
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Differences in level of depression between groups
timeFrame: After 12 months
Secondary outcomes:
measure: Resource Utilisation in Dementia
timeFrame: after 12 months
measure: Change in stress among carers
timeFrame: after 12 months
measure: Neuropsychiatric Inventory (NPI)
timeFrame: after 12 months
measure: Quality of life among people with dementia and carers
timeFrame: after 12 months
measure: Measures function in activities of daily living
timeFrame: after 12 months
measure: measure expressed emotion
timeFrame: after 12 months
measure: Locus of control among carers
timeFrame: after 12 months
measure: Mini mental status (MMSE)
timeFrame: after 12 months
measure: Differences in level of depression between groups
timeFrame: after 24 months
measure: Resource Utilisation in Dementia
timeFrame: after 24 months
measure: Change in stress among carers(RSS)
timeFrame: after 24 months
measure: Neuropsychiatric Inventory (NPI)
timeFrame: after 24 months
measure: Quality of life among people with dementia and carers(QOL-AD)
timeFrame: after 24 months
measure: Measures function in activities of daily living
timeFrame: after 24 months
measure: Locus of control among carers
timeFrame: after 24 months
measure: measure expressed emotion
timeFrame: after 24 months
measure: Mini mental status (MMSE)
timeFrame: after 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Centre for Ageing and Health
Study officials:
affiliation: Norwegian Centre for Ageing and Health
name: Knut Engedal, M.D.PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.