Thomas Brijoux1, Cornelia Kricheldorff, Michael H Ll, Steffi Bonfico. 1. Institute for Applied Research, Catholic University of Applied Sciences, Freiburg, Germany; Clinic for Geriatric Psychiatry, Center of Psychiatry, Emmendingen, Germany; Praxis f¨r Psychotherapie, Wiesbaden.
Abstract
BACKGROUND: Family members caring for persons with dementia are subject to multiple types of stress. Psychosocial help is recommended to lighten the emotional burden of care and can be of use in stabilizing the home-care situation. In this study conducted in rural areas in Germany, we tested whether volunteers with a special qualification for the assistance of families caring for dementia patients can support family members more effectively than conventional care companions. METHODS: In a randomized, controlled trial, 63 family members caring for persons with dementia were aided by specially qualified family companions (experimental intervention) or byconventional care companions (control intervention). The family members' quality of life was the primary endpoint and was evaluated at the end of the study in an intention-to-treat (ITT) analysis with t-tests. In an additional per-protocol (PP) analysis, differences that arose between groups at the outset of the study were accounted for. Secondary endpoints included reduced stress and better integration into the support system. RESULTS: The ITT analysis revealed no differences between groups in healthrelated quality of life on either the emotional or the somatic scale. The PP analysis, however, showed that the experimental intervention improved the emotional health-related quality of life of the patients' family members compared to the control group. The effect strength was intermediate (d = 0.57; p = 0.047). CONCLUSION: The difference between the findings of the PP and ITT analyses may be explained in part by the different distribution of severity of dementia in the two groups (experimental and control).
RCT Entities:
BACKGROUND: Family members caring for persons with dementia are subject to multiple types of stress. Psychosocial help is recommended to lighten the emotional burden of care and can be of use in stabilizing the home-care situation. In this study conducted in rural areas in Germany, we tested whether volunteers with a special qualification for the assistance of families caring for dementiapatients can support family members more effectively than conventional care companions. METHODS: In a randomized, controlled trial, 63 family members caring for persons with dementia were aided by specially qualified family companions (experimental intervention) or by conventional care companions (control intervention). The family members' quality of life was the primary endpoint and was evaluated at the end of the study in an intention-to-treat (ITT) analysis with t-tests. In an additional per-protocol (PP) analysis, differences that arose between groups at the outset of the study were accounted for. Secondary endpoints included reduced stress and better integration into the support system. RESULTS: The ITT analysis revealed no differences between groups in healthrelated quality of life on either the emotional or the somatic scale. The PP analysis, however, showed that the experimental intervention improved the emotional health-related quality of life of the patients' family members compared to the control group. The effect strength was intermediate (d = 0.57; p = 0.047). CONCLUSION: The difference between the findings of the PP and ITT analyses may be explained in part by the different distribution of severity of dementia in the two groups (experimental and control).
Authors: B Gandek; J E Ware; N K Aaronson; G Apolone; J B Bjorner; J E Brazier; M Bullinger; S Kaasa; A Leplege; L Prieto; M Sullivan Journal: J Clin Epidemiol Date: 1998-11 Impact factor: 6.437
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