Case Managers to Frail Older People a Randomized Controlled Trial

Frail Elderly Clinical Trial

Official title:

Case Managers to Frail Older People a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829594
• Other study ID #: 499/2008
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: April 9, 2013
• Start date: October 2006
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Frail Elderly

Intervention

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.

Locations

Country	Name	City	State
Sweden	Lund University, Faculty of Medicine, Department of Health Sciences	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kristensson J, Ekwall AK, Jakobsson U, Midlöv 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experiences of care	qualitative interviews with participants, next of kins and case managers	approximately one year	No
Primary	Health care consumption		two years (one year before vs after baseline)	No
Primary	Health care costs		two years (one year before vs after baseline)	No
Primary	Feelings of loneliness		baseline and then after 3,6,9,12,24 months	No
Primary	Depressive symptoms		baseline and then after 3,6,9,12,24 months	No
Primary	Health Related Quality of Life		baseline and then after 3,6,9,12,24 months	No
Primary	Number of falls		baseline and then after 3,6,9,12,24 months	No
Secondary	Life Satisfaction		baseline and then after 6,12,24 months	No
Secondary	Health complaints		baseline and then after 3,6,9,12,24 months	No
Secondary	Knowledge about prescribed drugs		baseline and then after 3,6,9,12,24 months	No
Secondary	Attitudes towards prescribed drugs		baseline and then after 3,6,9,12,24 months	No
Secondary	Drug use		baseline and then after 3,6,9,12,24 months	No
Secondary	Activities and social participation		baseline and then after 3,6,9,12,24 months	No
Secondary	Functional capacity		baseline and then after 3,6,9,12,24 months	No
Secondary	Balance		baseline and then after 3,6,9,12,24 months	No
Secondary	Timed up and go (TUG)		baseline and then after 3,6,9,12,24 months	No
Secondary	Risk of falling		baseline and then after 3,6,9,12,24 months	No
Secondary	Fear of Falling		baseline and then after 3,6,9,12,24 months	No