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

October 6, 2015 updated by: Norwegian Centre for Ageing and Health

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0407
        • Norwegian Centre for Ageing and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group, ordinary support
Home care as usual.
EXPERIMENTAL: A multidimensjonalt support program
•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.
Counseling, education and problem-solving in support group, ad hoc counseling

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Knut Engedal, M.D.PhD, Norwegian Centre for Ageing and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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