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Effect of Geriatric Medical Intervention On Elderly Referred For Rehabilitation (EGMIERR)

This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01506219
First received: December 28, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

A Meta-analysis from 2011 concludes that comprehensive geriatric assessment in hospitalized elderly makes older people to be alive and in their own homes. At present in Denmark, approximately 50% of elderly treated at rehabilitation transfer to nursing homes or specialised senior housing. To the investigators knowledge, there are no randomized studies evaluating the effectiveness of geriatric medical intervention to fragile elderly referred to these rehabilitation services. The aim of the study is to investigate the effect of geriatric medical intervention on frail elderly subjects, 65+ years old, referred to a rehabilitation unit in the Aarhus Municipality. The effect parameters are: frequency of hospital contacts, frequency of contacts with general practitioners and home care services, functional level, quality of life, institutionalization rate and mortality. Additionally, the investigators will assess the predictive factors that characterize elderly who benefit from the intervention. The project is an open randomized study. The follow-up period is three months. The intervention group: Participants will be assigned to an outpatient program in the Geriatric Department and assessed by a geriatrician within the first three days of admission to the rehabilitation unit (Vikaergaarden, Aarhus Municipality). Participants in the intervention group will also receive standard rehabilitation. Control group: Participants receive standard rehabilitation without involvement of the geriatrician. The investigators hypothesize that the geriatric medical intervention will benefit the frail elderly by reducing the frequency of hospital contacts by 25%. It is estimated that there will be a 20% dropout rate in both groups. A power analysis has demonstrated that 127 participants are required in each group to show a significant difference. The geriatric medical intervention includes: medical history, medication review, physical examination, paramedical clinical assessment, planning and follow-up (including medication optimization). The project is approved by the Data Protection Agency and the Central Denmark Region Committees for Biomedical Research Ethics.


Condition Intervention
Frail Elderly
 Other: Geriatric Medical Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Geriatric Medical Intervention On Elderly Referred For Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

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 and 3 months from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Usual services at Rehabilitation Unit and Geriatric Medical Intervention
 Other: Geriatric Medical Intervention
The geriatric medical intervention includes medical history, medication review, physical examination, paramedical clinical assessment, planning and follow-up incl. medication optimization. Medication adjustments and follow-up of the medication changes in the intervention group will be carried out using the STOP / START method by geriatrician.
No Intervention: Control
Usual services at Rehabilitation Unit

  Eligibility

Ages Eligible for Study:   65 Years and older
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 3 months
  2. Elderly in the palliative care at the time of referral
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506219

Contacts
Contact: Dmitri Zintchouk, MD (+45)26120675 dmizin@rm.dk
Contact: Else Marie Damsgaard, MD, DMSc (+45)78461935 elsedams@rm.dk

Locations
Denmark
Geriatric Department, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Dmitri Zintchouk, MD     (+45)26120675     dmizin@rm.dk    
Contact: Else Marie Damsgaard, MD, DMSc     (+45)78461935     elsedams@rm.dk    
Principal Investigator: Dmitri Zintchouk, MD            
Rehabilitation Unit Vikaergaarden Recruiting
Risskov, Denmark, 8240
Contact: Dmitri Zintchouk, MD     (+45)26120675     dmizin@rm.dk    
Contact: Else Marie Damsgaard, MD, DMSc     (+45)78461935     elsedams@rm.dk    
Principal Investigator: Dmitri Zintchouk, MD            
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

No publications provided

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: September 13, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Frail Elderly
Hospital contacts
Institutionalization
Functional level
Rehabilitation

ClinicalTrials.gov processed this record on June 17, 2013