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Completed

NCT Number: NCT01287767

A Support Program for Carers of Persons With Dementia

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Centre for Ageing and Health

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A multidimensional support program

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change in stress among carers

    Time frame: after 12 months

    Relatives Stress Scale(RSS) will be used

  3. Neuropsychiatric Inventory (NPI)

    Time frame: after 12 months

  4. Quality of life among people with dementia and carers

    Time frame: after 12 months

    The Quality of life in Alzheimer's disease (QOL-AD)

  5. Measures function in activities of daily living

    Time frame: after 12 months

    Lawton & Brody Instrumental and Performance activities daily living scale (IADL and PADL)

  6. measure expressed emotion

    Time frame: after 12 months

    Using Felt Expressed Emotion Rating Scale (FEERS)

  7. Locus of control among carers

    Time frame: after 12 months

  8. Mini mental status (MMSE)

    Time frame: after 12 months

  9. 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.

  10. Resource Utilisation in Dementia

    Time frame: after 24 months

  11. Change in stress among carers(RSS)

    Time frame: after 24 months

  12. Neuropsychiatric Inventory (NPI)

    Time frame: after 24 months

  13. Quality of life among people with dementia and carers(QOL-AD)

    Time frame: after 24 months

  14. Measures function in activities of daily living

    Time frame: after 24 months

  15. Locus of control among carers

    Time frame: after 24 months

  16. measure expressed emotion

    Time frame: after 24 months

  17. Mini mental status (MMSE)

    Time frame: after 24 months

Sponsors and collaborators

Lead sponsor

Norwegian Centre for Ageing and Health

Other

Collaborators

  • Kavli Research Center for Ageing and Dementia
  • The Research Council of Norway

Registry information

Official study title

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

Acronym: DIF2

Important dates

Study start
2009
Primary completion
2013
Study completion
2015
First posted
Feb 1, 2011
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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