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Open Access Highly Accessed Study protocol

Design of a randomized controlled study of a multi-professional and multidimensional intervention targeting frail elderly people

Katarina Wilhelmson12*, Anna Duner13, Kajsa Eklund14, Gunilla Gosman-Hedström14, Staffan Blomberg15, Henna Hasson16, Helena Gustafsson7, Sten Landahl1 and Synneve Dahlin-Ivanoff14

Author Affiliations

1 Vårdalinstitutet, The Swedish Institute for Health Sciences, University of Gothenburg and Lund, Sweden

2 Department of Public Health and Community Medicine/Social Medicine, Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

3 Department of Social Work, University of Gothenburg, Gothenburg, Sweden

4 Department of Clinical Neuroscience and Rehabilitation, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

5 School of Social Work and Welfare Studies, Lund University, Lund, Sweden

6 Department of Business Administration, Lund University School of Economics and Management, Lund, Sweden

7 Department of Physiology, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden

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BMC Geriatrics 2011, 11:24  doi:10.1186/1471-2318-11-24

Published: 14 May 2011

Abstract

Background

Frail elderly people need an integrated and coordinated care. The two-armed study "Continuum of care for frail elderly people" is a multi-professional and multidimensional intervention for frail community-dwelling elderly people. It was designed to evaluate whether the intervention programme for frail elderly people can reduce the number of visits to hospital, increase satisfaction with health and social care and maintain functional abilities. The implementation process is explored and analysed along with the intervention. In this paper we present the study design, the intervention and the outcome measures as well as the baseline characteristics of the study participants.

Methods/design

The study is a randomised two-armed controlled trial with follow ups at 3, 6 and 12 months. The study group includes elderly people who sought care at the emergency ward and discharged to their own homes in the community. Inclusion criteria were 80 years and older or 65 to 79 years with at least one chronic disease and dependent in at least one activity of daily living. Exclusion criteria were acute severely illness with an immediate need of the assessment and treatment by a physician, severe cognitive impairment and palliative care. The intention was that the study group should comprise a representative sample of frail elderly people at a high risk of future health care consumption. The intervention includes an early geriatric assessment, early family support, a case manager in the community with a multi-professional team and the involvement of the elderly people and their relatives in the planning process.

Discussion

The design of the study, the randomisation procedure and the protocol meetings were intended to ensure the quality of the study. The implementation of the intervention programme is followed and analysed throughout the whole study, which enables us to generate knowledge on the process of implementing complex interventions. The intervention contributes to early recognition of both the elderly peoples' needs of information, care and rehabilitation and of informal caregivers' need of support and information. This study is expected to show positive effects on frail elderly peoples' health care consumption, functional abilities and satisfaction with health and social care.

Trial registration

ClinicalTrials.gov: NCT01260493