A Support Program for Carers of Persons With Dementia

Depression Clinical Trial

— DIF2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287767
• Other study ID #: FI09
• Secondary ID: NFR189449
• Status: Completed
• Phase: N/A
• First received: January 26, 2011
• Last updated: October 6, 2015
• Start date: October 2009
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Norwegian Centre for Ageing and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia
• Depression

Intervention

Behavioral:
• A multidimensional support program
Counseling, education and problem-solving in support group, ad hoc counseling

Locations

Country	Name	City	State
Norway	Norwegian Centre for Ageing and Health	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian Centre for Ageing and Health	Kavli Research Center for Ageing and Dementia, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in level of depression between groups	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	No
Secondary	Resource Utilisation in Dementia	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	No
Secondary	Change in stress among carers	Relatives Stress Scale(RSS) will be used	after 12 months	No
Secondary	Neuropsychiatric Inventory (NPI)		after 12 months	No
Secondary	Quality of life among people with dementia and carers	The Quality of life in Alzheimer's disease (QOL-AD)	after 12 months	No
Secondary	Measures function in activities of daily living	Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)	after 12 months	No
Secondary	measure expressed emotion	Using Felt Expressed Emotion Rating Scale (FEERS)	after 12 months	No
Secondary	Locus of control among carers		after 12 months	No
Secondary	Mini mental status (MMSE)		after 12 months	No
Secondary	Differences in level of depression between groups	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	No
Secondary	Resource Utilisation in Dementia		after 24 months	No
Secondary	Change in stress among carers(RSS)		after 24 months	No
Secondary	Neuropsychiatric Inventory (NPI)		after 24 months	No
Secondary	Quality of life among people with dementia and carers(QOL-AD)		after 24 months	No
Secondary	Measures function in activities of daily living		after 24 months	No
Secondary	Locus of control among carers		after 24 months	No
Secondary	measure expressed emotion		after 24 months	No
Secondary	Mini mental status (MMSE)		after 24 months	No