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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Research Council of Norway
Kavli Research Center for Ageing and Dementia
Information provided by (Responsible Party):
Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier:
NCT01287767
First received: January 26, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Dementia
Depression
Behavioral: A multidimensional support program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Support Program for Carers of Persons With Dementia - a 24 Months RCT

Resource links provided by NLM:


Further study details as provided by Norwegian Centre for Ageing and Health:

Primary Outcome Measures:
  • Differences in level of depression between groups [ Time Frame: After 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Resource Utilisation in Dementia [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in stress among carers [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    Relatives Stress Scale(RSS) will be used

  • Neuropsychiatric Inventory (NPI) [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
  • Quality of life among people with dementia and carers [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    The Quality of life in Alzheimer's disease (QOL-AD)

  • Measures function in activities of daily living [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)

  • measure expressed emotion [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
    Using Felt Expressed Emotion Rating Scale (FEERS)

  • Locus of control among carers [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
  • Mini mental status (MMSE) [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
  • Differences in level of depression between groups [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
    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.

  • Resource Utilisation in Dementia [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Change in stress among carers(RSS) [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Quality of life among people with dementia and carers(QOL-AD) [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Measures function in activities of daily living [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Locus of control among carers [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • measure expressed emotion [ Time Frame: after 24 months ] [ Designated as safety issue: No ]
  • Mini mental status (MMSE) [ Time Frame: after 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: October 2009
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: A multidimensional support program
Counseling, education and problem-solving in support group, ad hoc counseling

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287767

Locations
Norway
Norwegian Centre for Ageing and Health
Oslo, Norway, 0407
Sponsors and Collaborators
Norwegian Centre for Ageing and Health
The Research Council of Norway
Kavli Research Center for Ageing and Dementia
Investigators
Principal Investigator: Knut Engedal, M.D.PhD Norwegian Centre for Ageing and Health
  More Information

No publications provided

Responsible Party: Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier: NCT01287767     History of Changes
Other Study ID Numbers: FI09, NFR189449
Study First Received: January 26, 2011
Last Updated: February 3, 2014
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian Centre for Ageing and Health:
Dementia
Depression
Burden of care
Psychosocial intervention
Family home care

Additional relevant MeSH terms:
Dementia
Depression
Depressive Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 28, 2014