NCT01260493

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 15, 2014

Completed
Last Updated

July 15, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

November 30, 2010

Results QC Date

January 22, 2014

Last Update Submit

June 11, 2014

Conditions

Keywords

very frailcase managerintegrated caremultiprofessionalintervention

Outcome Measures

Primary Outcomes (3)

  • Health Care Consumption

    Number of hospital days and admission will be analysed

    1 year

  • Dependence in Activities of Daily Living

    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

    1 year

Study Arms (2)

Conventional care, controlgroup

NO INTERVENTION

conventional care, control group

integrated health care chain

EXPERIMENTAL

integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers

Other: integrated health care chain

Interventions

Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers

integrated health care chain

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, 405 30, Sweden

Location

Related Publications (3)

  • 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.

Results Point of Contact

Title
Professor Synneve Dahlin-Ivanoff ( Research leader)
Organization
Vårdalinstitute, University of Gothenburg

Study Officials

  • Katarina Wilhelmson, MD,PhD

    Göteborg University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 15, 2010

Study Start

October 1, 2008

Primary Completion

June 1, 2010

Study Completion

October 1, 2011

Last Updated

July 15, 2014

Results First Posted

July 15, 2014

Record last verified: 2014-06

Locations