Frail Elderly PeopleNCT01260493
Continuum of Care for Frail Elderly People
A study testing integrated health care chain in people with Frail Elderly People, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly People
- What is being tested?
- integrated health care chain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Frail Elderly People
- Being tested
- integrated health care chain
- Keywords
- very frail, case manager, integrated care, multiprofessional, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated health care chainOther
Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: integrated health care chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Consumption
Number of hospital days and admission will be analysed
Measured: 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.
Measured: 1 year
Satisfaction With Health and Social Care
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frail Elderly PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- VinnVård
- Responsible party
- Sponsor
- Investigators
- Katarina Wilhelmson, MD,PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260493
- Sponsor's protocol ID
- VårdkedjaVårdal
- Status last verified
- Jun 2014
- First submitted
- 30 Nov 2010
- Last updated
- 15 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 23875866Hasson 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.
PubMed 22436121Wilhelmson 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.
PubMed 21569570
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuum of Care, From the Emergency Ward to Living at Home - Implementation and Evaluation of an Intervention for Frail Elderly People
- ClinicalTrials.gov ID
- NCT01260493
- Acronym / sponsor ID
- VårdkedjaVårdal
- Conditions
- Frail Elderly People
- Keywords
- very frail, case manager, integrated care, multiprofessional, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Vardalinstitutet The Swedish Institute for Health SciencesUniversity, hospital or other
- Collaborators
- VinnVård
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Posted 15 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional care, controlgroup | No intervention | –conventional care, control group |
| integrated health care chain | Experimental | Other: integrated health care chainintegrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated health care chainGeriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers | Other | integrated health care chain |
Primary outcome
Health Care Consumption
Time frame: 1 year
Number of hospital days and admission will be analysed
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.
Satisfaction With Health and Social Care
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23875866Eklund 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.
- Derived from this study: PubMed 22436121Hasson 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.
- Derived from this study: PubMed 21569570Wilhelmson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Wilhelmson, MD,PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated health care chain in people with Frail Elderly People, run by Vardalinstitutet The Swedish Institute for Health Sciences at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Care Consumption (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260493, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.