- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01260493
Continuum of Care for Frail Elderly People
Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
The present study "Continuum of care for frail elderly people" form part of the research programme "Support for frail elderly persons - from prevention to palliation" (www.vardalinstitutet.net) which comprises research into three interventions. The program comprises interventions addressing frail elderly people in different phases of the disablement process, from elderly people who are beginning to develop frailty to very frail elderly people receiving palliative care.
The intervention "Continuum of care for frail elderly people" addresses elderly people who are frail and that have a great risk of high health care consumption. The hypothesis is that an intervention program for frail elderly people can reduce the number of visits to the emergency department, increase the life satisfaction and maintain the functional ability. The intervention, including an early geriatric assessment at the emergency department, early family support, a case manager in the community with a multi-professional team and active follow-up by the case manager, contributes to early recognition of the elderly people's need of information, care and rehabilitation and of informal caregivers' need of information. It enhances the transfer of information and integrates the care between different caregivers and different care levels, thereby better recognize frail elderly people's needs. Specifically, this study is expected to show that the intervention has a positive effect on the frail elderly person's functional ability, life satisfaction, satisfaction with health and social care, and health care consumption.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gothenburg, Sweden, 405 30
- University of Gothenburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 80 years and older or 65 to 79 years and having at least one chronic disease and being dependent in at least one activity of daily living
Exclusion Criteria:
- acute severely sick who immediately needs the assessment of a physician (within ten minutes)
- those with diagnosis of dementia (or severe cognitive impairment)
- patients in palliative care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Conventional care, controlgroup
conventional care, control group
|
|
Experimental: integrated health care chain
integrated health care chain.
Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers
|
Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Care Consumption
Time Frame: 1 year
|
Number of hospital days and admission will be analysed
|
1 year
|
Dependence in Activities of Daily Living
Time Frame: 1 year
|
Changes in number of person dependent in one or more daily activity from baseline to follow-up.
|
1 year
|
Satisfaction With Health and Social Care
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Katarina Wilhelmson, MD,PhD, Göteborg University
Publications and helpful links
General Publications
- Eklund K, Wilhelmson K, Gustafsson H, Landahl S, Dahlin-Ivanoff S. One-year outcome of frailty indicators and activities of daily living following the randomised controlled trial: "Continuum of care for frail older people". BMC Geriatr. 2013 Jul 22;13:76. doi: 10.1186/1471-2318-13-76.
- Hasson H, Blomberg S, Duner A. Fidelity and moderating factors in complex interventions: a case study of a continuum of care program for frail elderly people in health and social care. Implement Sci. 2012 Mar 22;7:23. doi: 10.1186/1748-5908-7-23.
- Wilhelmson K, Duner A, Eklund K, Gosman-Hedstrom G, Blomberg S, Hasson H, Gustafsson H, Landahl S, Dahlin-Ivanoff S. Design of a randomized controlled study of a multi-professional and multidimensional intervention targeting frail elderly people. BMC Geriatr. 2011 May 14;11:24. doi: 10.1186/1471-2318-11-24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VårdkedjaVårdal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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