Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Case Managers to Frail Older People a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829594
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Jimmie Kristensson, Lund University

Brief 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.

Condition or disease Intervention/treatment Phase
Frail Elderly Other: Case management Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Case Managers to Frail Older People a Randomized Controlled Trial
Study Start Date : October 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Case Management Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Experiences of care [ Time Frame: approximately one year ]
    qualitative interviews with participants, next of kins and case managers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829594


Locations
Layout table for location information
Sweden
Lund University, Faculty of Medicine, Department of Health Sciences
Lund, Sweden, SE-22100
Sponsors and Collaborators
Lund University
Investigators
Layout table for investigator information
Principal Investigator: Ingalill Rahm Hallberg, PhD Lund University
Publications of Results:
Layout table for additonal information
Responsible Party: Jimmie Kristensson, PhD, Senior Lecturer, Lund University
ClinicalTrials.gov Identifier: NCT01829594    
Other Study ID Numbers: 499/2008
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Jimmie Kristensson, Lund University:
Case Management
Frail Elderly
Health Services Administration
Delivery of Health Care
Accidental Falls
Health Status
Health Care Economics