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CompletedNCT01829594Updated Apr 11, 2013

Case Managers to Frail Older People a Randomized Controlled Trial

An interventional study of Case management in Frail Elderly, sponsored by Lund University. Completed at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-04-11.

Sponsored by Lund University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
153
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Frail Elderly

Keywords

  • Case Management
  • Frail Elderly
  • Health Services Administration
  • Delivery of Health Care
  • Accidental Falls
  • Health Status
  • Health Care Economics
03

In context

Lead sponsor

Lund University is the lead sponsor of 230 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    Case Management

    Other: Case management

Interventions

  • OtherCase management

    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.

06

What researchers measure

Primary outcomes

  1. Health care consumption

    Time frame: two years (one year before vs after baseline)

  2. Health care costs

    Time frame: two years (one year before vs after baseline)

  3. Feelings of loneliness

    Time frame: baseline and then after 3,6,9,12,24 months

  4. Depressive symptoms

    Time frame: baseline and then after 3,6,9,12,24 months

  5. Health Related Quality of Life

    Time frame: baseline and then after 3,6,9,12,24 months

  6. Number of falls

    Time frame: baseline and then after 3,6,9,12,24 months

Secondary outcomes

  1. Life Satisfaction

    Time frame: baseline and then after 6,12,24 months

  2. Health complaints

    Time frame: baseline and then after 3,6,9,12,24 months

  3. Knowledge about prescribed drugs

    Time frame: baseline and then after 3,6,9,12,24 months

  4. Attitudes towards prescribed drugs

    Time frame: baseline and then after 3,6,9,12,24 months

  5. Drug use

    Time frame: baseline and then after 3,6,9,12,24 months

  6. Activities and social participation

    Time frame: baseline and then after 3,6,9,12,24 months

  7. Functional capacity

    Time frame: baseline and then after 3,6,9,12,24 months

  8. Balance

    Time frame: baseline and then after 3,6,9,12,24 months

  9. Timed up and go (TUG)

    Time frame: baseline and then after 3,6,9,12,24 months

  10. Risk of falling

    Time frame: baseline and then after 3,6,9,12,24 months

  11. Fear of Falling

    Time frame: baseline and then after 3,6,9,12,24 months

Other outcomes

  1. Experiences of care

    qualitative interviews with participants, next of kins and case managers

    Time frame: approximately one year

07

Study locations

1 site
  • Lund University, Faculty of Medicine, Department of Health Sciences
    Lund, SE-22100, Sweden
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01829594
Lead sponsor
Lund University
Responsible party
Jimmie Kristensson (PhD, Senior Lecturer, Lund University) — Principal investigator
First posted
Apr 11, 2013
Start date
Oct 2006
Primary completion
Apr 2011
Completion
Apr 2012
Last update
Apr 11, 2013

Study contacts

Ingalill Rahm Hallberg, PhD
principal investigator · Lund University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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