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A Support Program for Carers of Persons With Dementia (DIF2)

N

Norwegian Centre for Ageing and Health

Status

Completed

Conditions

Depression
Dementia

Treatments

Behavioral: A multidimensional support program

Study type

Interventional

Funder types

Other

Identifiers

NCT01287767
NFR189449 (Other Identifier)
FI09

Details and patient eligibility

About

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.

Full 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.

Enrollment

230 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

230 participants in 2 patient groups

Control group, ordinary support
No Intervention group
Description:
Home care as usual.
A multidimensjonalt support program
Experimental group
Description:
•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.
Treatment:
Behavioral: A multidimensional support program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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