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A Support Program for Carers of Persons With Dementia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01287767
Acronym
DIF2
Enrollment
230
Registered
2011-02-01
Start date
2009-10-31
Completion date
2015-01-31
Last updated
2015-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Depression

Keywords

Dementia, Depression, Burden of care, Psychosocial intervention, Family home 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.

Interventions

BEHAVIORALA multidimensional support program

Counseling, education and problem-solving in support group, ad hoc counseling

Sponsors

The Research Council of Norway
CollaboratorOTHER
Kavli Research Center for Ageing and Dementia
CollaboratorUNKNOWN
Norwegian Centre for Ageing and Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in level of depression between groupsAfter 12 monthsCornell 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

MeasureTime frameDescription
Change in stress among carersafter 12 monthsRelatives Stress Scale(RSS) will be used
Neuropsychiatric Inventory (NPI)after 12 months
Quality of life among people with dementia and carersafter 12 monthsThe Quality of life in Alzheimer's disease (QOL-AD)
Measures function in activities of daily livingafter 12 monthsLawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)
measure expressed emotionafter 12 monthsUsing Felt Expressed Emotion Rating Scale (FEERS)
Resource Utilisation in Dementiaafter 12 monthsResource 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.
Mini mental status (MMSE)after 12 months
Differences in level of depression between groupsafter 24 monthsCornell 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.
Change in stress among carers(RSS)after 24 months
Quality of life among people with dementia and carers(QOL-AD)after 24 months
Locus of control among carersafter 12 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026