Continuum of Care for Frail Elderly People

• Sponsor: Vardalinstitutet The Swedish Institute for Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01260493
• Collaborator: VinnVård (Other)
• Enrollment: 181
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frail Elderly People	Other: integrated health care chain	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

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	Other: integrated health care chain; Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers

Outcome Measures

Primary Outcome Measures

1. Health Care Consumption [1 year]

   Number of hospital days and admission will be analysed

2. Dependence in Activities of Daily Living [1 year]

   Changes in number of person dependent in one or more daily activity from baseline to follow-up.

3. Satisfaction With Health and Social Care [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gothenburg	Gothenburg		Sweden	405 30

Sponsors and Collaborators

• Vardalinstitutet The Swedish Institute for Health Sciences
• VinnVård

Investigators

• Principal Investigator: Katarina Wilhelmson, MD,PhD, Göteborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vardalinstitutet The Swedish Institute for Health Sciences
• ClinicalTrials.gov Identifier: NCT01260493
• Other Study ID Numbers: VårdkedjaVårdal
• First Posted: Dec 15, 2010
• Last Update Posted: Jul 15, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Vardalinstitutet The Swedish Institute for Health Sciences: very frail; case manager; integrated care; multiprofessional; intervention

Study Results

Participant Flow

Recruitment Details	recrutment period October 2008 to July 2011
Pre-assignment Detail	exluded due to sheltered housing (n=2), dementia (n=1),palliative care (n=1) and died before baseline (n=4), declined particapation (n=12)

Arm/Group Title	Conventional Care, Controlgroup	Integrated Health Care Chain
Arm/Group Description	conventional care, control group	integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
Period Title: Overall Study
STARTED	92	89
COMPLETED	76	85
NOT COMPLETED	16	4

Baseline Characteristics

Arm/Group Title	Conventional Care, Controlgroup	Integrated Health Care Chain	Total
Arm/Group Description	conventional care, control group	integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers	Total of all reporting groups
Overall Participants	76	85	161
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	76 100%	85 100%	161 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.1 (5.8)	82.7 (5.2)	82.4 (5.5)
Sex: Female, Male (Count of Participants)
Female	42 55.3%	47 55.3%	89 55.3%
Male	34 44.7%	38 44.7%	72 44.7%
Region of Enrollment (participants) [Number]
Sweden	76 100%	85 100%	161 100%

Outcome Measures

1. Primary Outcome

Title	Health Care Consumption
Description	Number of hospital days and admission will be analysed
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

2. Primary Outcome

Title	Dependence in Activities of Daily Living
Description	Changes in number of person dependent in one or more daily activity from baseline to follow-up.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Care, Controlgroup	Integrated Health Care Chain
Arm/Group Description	conventional care, control group	integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
Measure Participants	76	85
Number [participants]	18 23.7%	33 38.8%

3. Primary Outcome

Title	Satisfaction With Health and Social Care
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Conventional Care, Controlgroup		Integrated Health Care Chain
Arm/Group Description	conventional care, control group		integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
All Cause Mortality
	Conventional Care, Controlgroup		Integrated Health Care Chain
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Care, Controlgroup		Integrated Health Care Chain
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/85 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Care, Controlgroup		Integrated Health Care Chain
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/85 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.