Comprehensive Geriatric Care In Elderly Referred To A Rehabilitation Unit (CGCERU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01506219
First received: December 28, 2011
Last updated: June 21, 2016
Last verified: June 2016
  Purpose

Introduction:

Elderly with multiple illnesses represent the fastest growing sector of society and make increasing demands on all sectors of the health care system, particularly in community rehabilitation units due to shorter time of stay in acute care units and hospitals. The aim of this study is to investigate the effect of geriatrician-performed comprehensive geriatric assessments and intervention with follow up (CGC) in elderly referred to a rehabilitation unit.

Methods:

The study is a prospective randomized controlled trial. Settings: two community care rehabilitation units in Aarhus Municipality, Denmark. Inclusion: elderly aged 65 and older from home or hospital. Exclusion: elderly who received palliative care or had been assessed by a geriatrician during the past month. Intervention: medical history, physical examination, blood tests, medication adjustment and follow up by a geriatrician. Control: standard care with the general practitioners (GPs) as back-up. Hospital contacts (primary outcome), GP contacts, activities of daily living (ADL), physical and cognitive functions, quality of life, institutionalization, medication status, and mortality were assessed at day 30 and 90 after arrival at the rehabilitation unit. preliminary

Preliminary results:

In total, 370 persons were randomized (184 control/186 intervention group). The mean age was 77.9±7.9/78.3±8.3 years. No difference in mortality was demonstrated. Analyses on hospital contacts, GP contacts, activities of daily living (ADL), physical and cognitive functions, quality of life, institutionalization, medication status are ongoing.


Condition Intervention
Fragility
Other: geriatrician-performed CGA and intervention with follow up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comprehensive Geriatric Care In Elderly Referred To A Rehabilitation Unit

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Number of hospital contacts [ Time Frame: 3 months from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of contacts with general practitioner [ Time Frame: 3 months from baseline ] [ Designated as safety issue: No ]
  • Number of contacts with home care services [ Time Frame: 3 months from baseline ] [ Designated as safety issue: No ]
  • Changes in functional level (MBI, CAM, MMSE) [ Time Frame: Changes at 10 days, 30 days and 90 days from baseline ] [ Designated as safety issue: No ]
    Modificeret Barthel Index (MBI), The Confusion Assessment Method (CAM) and Mini Mental State Examination (MMSE)

  • Depression List (DL) [ Time Frame: Changes at 10 days, 30 days and 90 days from baseline ] [ Designated as safety issue: No ]
    Depression List (DL)

  • Institutionalization rate [ Time Frame: Changes at 10 days and 3 months from baseline ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 1 month, 3 months and 6 months from baseline ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: November 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Usual services at Rehabilitation Unit and geriatrician-performed CGA and intervention with follow up
Other: geriatrician-performed CGA and intervention with follow up
Medical history, physical examination, blood tests, medication adjustment and follow up by a geriatrician
No Intervention: Control
Usual services at Rehabilitation Unit

Detailed Description:
A new model of care for elderly referred to community rehabilitation was developed and implemented. The potential benefits of this model will be compared with usual care in a community rehabilitation unit in a pragmatic randomized clinical trial. We hypothesized that the geriatrician-performed CGC in elderly referred to a rehabilitation unit will reduce the hospital contacts by 25 % without increase in mortality and contacts to GPs and home care services. We expect that this model of care will prevent deterioration in ADL, physical and cognitive functioning, and reduce the risk of institutionalization. If the results are positive, community rehabilitation services should change their routines for treatment of this population accordingly.
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 65+ years old in Aarhus Municipality
  2. Referral to rehabilitation unit by general practitioner, home care services services or hospital department
  3. Written informed consent

Exclusion Criteria:

  1. Elderly, who received Comprehensive Geriatric Assessment within last 1 month
  2. Elderly in the palliative care at the time of referral
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506219

Locations
Denmark
Geriatric Department, Aarhus University Hospital
Aarhus, Denmark, 8000
Rehabilitation Unit Vikaergaarden and Thorsgaarden
Aarhus, Denmark, 8240
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Dmitri Zintchouk, MD Geriatric Department, Aarhus University Hospital, Denmark
Study Director: Else Marie Damsgaard, MD, DMSc Geriatric Department, Aarhus University Hospital, Denmark
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01506219     History of Changes
Other Study ID Numbers: NZ-151111-VHDZ 
Study First Received: December 28, 2011
Last Updated: June 21, 2016
Health Authority: Denmark: National Board of Health
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Aarhus:
Randomized controlled trial
Comprehensive geriatric care
Hospital contacts
Activity of daily living
Quality of life
Rehabilitation

ClinicalTrials.gov processed this record on July 28, 2016