Frail ElderlyNCT01829594
Case Managers to Frail Older People a Randomized Controlled Trial
A study testing Case management in people with Frail Elderly, run by Lund University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2006to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Lund University, Faculty of Medicine, Department of Health Sciences
Lund, SE-22100
About this study
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.
- Conditions
- Frail Elderly
- Being tested
- Case management
- Keywords
- Case Management, Frail Elderly, Health Services Administration, Delivery of Health Care, Accidental Falls, Health Status, Health Care Economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Case Management | Experimental | Not described Receives: Other: Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care consumption
Measured: two years (one year before vs after baseline)
Health care costs
Measured: two years (one year before vs after baseline)
Feelings of loneliness
Measured: baseline and then after 3,6,9,12,24 months
Depressive symptoms
Measured: baseline and then after 3,6,9,12,24 months
Health Related Quality of Life
Measured: baseline and then after 3,6,9,12,24 months
Number of falls
Measured: baseline and then after 3,6,9,12,24 months
Secondary outcomes (11)
Life Satisfaction
Measured: baseline and then after 6,12,24 months
Health complaints
Measured: baseline and then after 3,6,9,12,24 months
Knowledge about prescribed drugs
Measured: baseline and then after 3,6,9,12,24 months
Attitudes towards prescribed drugs
Measured: baseline and then after 3,6,9,12,24 months
Drug use
Measured: baseline and then after 3,6,9,12,24 months
Activities and social participation
Measured: baseline and then after 3,6,9,12,24 months
Functional capacity
Measured: baseline and then after 3,6,9,12,24 months
Balance
Measured: baseline and then after 3,6,9,12,24 months
Timed up and go (TUG)
Measured: baseline and then after 3,6,9,12,24 months
Risk of falling
Measured: baseline and then after 3,6,9,12,24 months
Fear of Falling
Measured: baseline and then after 3,6,9,12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startOct 2006
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmie Kristensson, Lund University
- Investigators
- Ingalill Rahm Hallberg, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829594
- Sponsor's protocol ID
- 499/2008
- Status last verified
- Apr 2013
- First submitted
- 9 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristensson J, Ekwall AK, Jakobsson U, Midlov P, Hallberg IR. Case managers for frail older people: a randomised controlled pilot study. Scand J Caring Sci. 2010 Dec;24(4):755-63. doi: 10.1111/j.1471-6712.2010.00773.x.
PubMed 20409057
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Managers to Frail Older People a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01829594
- Acronym / sponsor ID
- 499/2008
- Conditions
- Frail Elderly
- Keywords
- Case Management, Frail Elderly, Health Services Administration, Delivery of Health Care, Accidental Falls, Health Status, Health Care Economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Management | Experimental | Other: Case management |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Case managementNurses 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. | Other | Case Management |
Primary outcome
Health care consumption
Time frame: two years (one year before vs after baseline)
Health care costs
Time frame: two years (one year before vs after baseline)
Feelings of loneliness
Time frame: baseline and then after 3,6,9,12,24 months
Depressive symptoms
Time frame: baseline and then after 3,6,9,12,24 months
Health Related Quality of Life
Time frame: baseline and then after 3,6,9,12,24 months
Number of falls
Time frame: baseline and then after 3,6,9,12,24 months
11 secondary outcomes
Life Satisfaction
Time frame: baseline and then after 6,12,24 months
Health complaints
Time frame: baseline and then after 3,6,9,12,24 months
Knowledge about prescribed drugs
Time frame: baseline and then after 3,6,9,12,24 months
Attitudes towards prescribed drugs
Time frame: baseline and then after 3,6,9,12,24 months
Drug use
Time frame: baseline and then after 3,6,9,12,24 months
Activities and social participation
Time frame: baseline and then after 3,6,9,12,24 months
Functional capacity
Time frame: baseline and then after 3,6,9,12,24 months
Balance
Time frame: baseline and then after 3,6,9,12,24 months
Timed up and go (TUG)
Time frame: baseline and then after 3,6,9,12,24 months
Risk of falling
Time frame: baseline and then after 3,6,9,12,24 months
Fear of Falling
Time frame: baseline and then after 3,6,9,12,24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
- Results publication: PubMed 20409057Kristensson J, Ekwall AK, Jakobsson U, Midlov P, Hallberg IR. Case managers for frail older people: a randomised controlled pilot study. Scand J Caring Sci. 2010 Dec;24(4):755-63. doi: 10.1111/j.1471-6712.2010.00773.x.
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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.
Ingalill Rahm Hallberg, PhD principal investigator
Lund 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 Case management in people with Frail Elderly, run by Lund University 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 6 inclusion and 0 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 11 Apr 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: two years (one year before vs after baseline)). The study lists 6 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 NCT01829594, which also lists 1 linked publication.
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 11 Apr 2013.