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

Status

Completed

Conditions

Intervention / Treatment

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

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

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
Experimental: Case 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.

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)
two years (one year before vs after baseline)
Health care costs
Time Frame: two years (one year before vs after baseline)
two years (one year before vs after baseline)
Feelings of loneliness
Time Frame: baseline and then after 3,6,9,12,24 months
baseline and then after 3,6,9,12,24 months
Depressive symptoms
Time Frame: baseline and then after 3,6,9,12,24 months
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
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
baseline and then after 3,6,9,12,24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Life Satisfaction
Time Frame: baseline and then after 6,12,24 months
baseline and then after 6,12,24 months
Health complaints
Time Frame: baseline and then after 3,6,9,12,24 months
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
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
baseline and then after 3,6,9,12,24 months
Drug use
Time Frame: baseline and then after 3,6,9,12,24 months
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
baseline and then after 3,6,9,12,24 months
Functional capacity
Time Frame: baseline and then after 3,6,9,12,24 months
baseline and then after 3,6,9,12,24 months
Balance
Time Frame: baseline and then after 3,6,9,12,24 months
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
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
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
baseline and then after 3,6,9,12,24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences of care
Time Frame: approximately one year
qualitative interviews with participants, next of kins and case managers
approximately one year

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

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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