- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01829594
Case Managers to Frail Older People a Randomized Controlled Trial
April 9, 2013 updated by: Jimmie Kristensson, Lund University
The aim of is to test the effects of a model for care (case management) to older people with high healthcare consumption and functional dependency on healthcare consumption, quality of life, functional ability and experiences of care.
Study Overview
Study Type
Interventional
Enrollment (Actual)
153
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lund, Sweden, SE-22100
- Lund University, Faculty of Medicine, Department of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 65 or over
- need help with at least two activities of daily living
- been admitted to hospital on at least two occasions, or
- have had at least four contacts with outpatient or primary care during the previous twelve months,
- be able to communicate verbally
- have no cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Case Management
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Nurses and a physiotherapist (PT) worked as case managers (CM).
The intervention lasted 12 months and comprised 4 dimensions.
The first was traditional CM tasks: assessment, planning, monitoring, care coordination and evaluation.
Home visits were made at least once a month.
The second and third was general and specific information related to the participants' situation.
The fourth part included aspects of continuity and safety.
The PT also paid home visits and made an assessment regarding physical function and balance.
The intervention consisted of multidimensional prevention of falls and/or consequences of falls, and supporting and motivating the participant to increased physical activity.
When those in the control group had participated for 12 months they were offered the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health care consumption
Time Frame: two years (one year before vs after baseline)
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two years (one year before vs after baseline)
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Health care costs
Time Frame: two years (one year before vs after baseline)
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two years (one year before vs after baseline)
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Feelings of loneliness
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Depressive symptoms
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Health Related Quality of Life
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Number of falls
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Life Satisfaction
Time Frame: baseline and then after 6,12,24 months
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baseline and then after 6,12,24 months
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Health complaints
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Knowledge about prescribed drugs
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
|
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Attitudes towards prescribed drugs
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Drug use
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Activities and social participation
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Functional capacity
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Balance
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Timed up and go (TUG)
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Risk of falling
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Fear of Falling
Time Frame: baseline and then after 3,6,9,12,24 months
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baseline and then after 3,6,9,12,24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Experiences of care
Time Frame: approximately one year
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qualitative interviews with participants, next of kins and case managers
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approximately one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ingalill Rahm Hallberg, PhD, Lund University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
April 9, 2013
First Submitted That Met QC Criteria
April 9, 2013
First Posted (Estimate)
April 11, 2013
Study Record Updates
Last Update Posted (Estimate)
April 11, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 499/2008
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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