A Support Program for Carers of Persons With Dementia

NCT01287767 | Completed DMC

• 2 other identifiers: FI09NFR189449
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Depression

Keywords

Dementia; Depression; Burden of care; Psychosocial intervention; Family home care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

• Resource Utilisation in Dementia

  after 12 months

• Change in stress among carers

  after 12 months

• Neuropsychiatric Inventory (NPI)

  after 12 months

• Quality of life among people with dementia and carers

  after 12 months

• Measures function in activities of daily living

  after 12 months

Study Arms (2)

Control group, ordinary support

NO INTERVENTION

Home care as usual.

A multidimensjonalt support program

EXPERIMENTAL

•Behavioral (e.g., Psychotherapy, Lifestyle Counseling) The family will receive individual consulting, teaching and problem solving in support groups.

Behavioral: A multidimensional support program

Interventions

A multidimensional support program BEHAVIORAL

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

A multidimensjonalt support program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Norwegian Centre for Ageing and Health: lead
• The Research Council of Norway: collaborator
• Kavli Research Center for Ageing and Dementia: collaborator

Study Sites (1)

Norwegian Centre for Ageing and Health

Oslo, Oslo County, 0407, Norway

Location

Related Publications (1)

• Bjorge H, Kvaal K, Ulstein I. The effect of psychosocial support on caregivers' perceived criticism and emotional over-involvement of persons with dementia: an assessor-blinded randomized controlled trial. BMC Health Serv Res. 2019 Oct 24;19(1):744. doi: 10.1186/s12913-019-4551-x.

  PMID: 31651321 DERIVED

MeSH Terms

Conditions

Dementia; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Knut Engedal, M.D.PhD

  Norwegian Centre for Ageing and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: February 1, 2011
• Study Start: October 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

NO (1)