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Geriatrician-performed Comprehensive Geriatric Care in a Community Rehabilitation Unit (GCGCCRU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506219
First Posted: January 9, 2012
Last Update Posted: October 17, 2017
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.
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
  Purpose

Introduction:

Older adults 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 care (CGC) in older people referred to a community rehabilitation unit.

Methods:

The study is a prospective randomized controlled trial. Settings: two community care rehabilitation units in Aarhus Municipality, Denmark. Inclusion: persons aged 65 and older from home or hospital. Exclusion: persons 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 related treatments performed by a geriatrician. Control: usual care in a community rehabilitation unit. Number of hospital admissions and emergency department (ED) visits (primary outcome), number of GP contacts, activities of daily living, physical and cognitive functioning, quality of life, data on institutionalization, medication status, and mortality are assessed at day 30 and 90 after arrival at the rehabilitation unit.

Project status:

The outpatient CGC model is developed, implemented and compared with usual care in a pragmatic RCT.


Condition Intervention
Fragility Procedure: Geriatrician-performed CGC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A pragmatic open assessor-blinded clinical randomized controlled trial with two parallel groups.
Masking: Single (Outcomes Assessor)
Masking Description:

The geriatrician was blinded to the primary endpoint data that were drawn from the National Patient Registry via Researcher Service. The dataset was generated by the Registry's staff blinded to the patient allocation.

It was impossible to blind the participants and their relatives or the geriatrician and the rehabilitation units' staff to the allocation group.

The research nurse was not blinded to patient allocation for practical reasons. The research occupational therapist was blinded to treatment allocation.

Primary Purpose: Treatment
Official Title: Geriatrician-performed Comprehensive Geriatric Care in Older Adults Referred to a Community Rehabilitation Unit

Resource links provided by NLM:


Further study details as provided by University of Aarhus ( Aarhus University Hospital ):

Primary Outcome Measures:
  • Number of hospital admissions and ED visits (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation units ]
    Numbers of all hospital admissions and ED visits


Secondary Outcome Measures:
  • Number of GP contacts (the primary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay) ]
    Numbers of all out of hour GP visits or phone calls, daytime GP consultations and visits, phone and email consultations, and other GP services

  • Changes in functional status measured by with the need for support from the district nurses [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    Percentages of participants with the need for support from the district nurses

  • Changes in ADL function measured by the Modified Barthel-100 Index (MBI) [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    MBI is a 10-item instrument that provides a score of basic daily activities. The scores range from 0-100, with a higher score indicating greater independence. The MBI changes calculated as between-the-groups means differences, and as percentage of participants who worsened/did not change vs who improved their ADL

  • Changes in cognitive functioning measured by the Confusion Assessment Method (CAM) [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    CAM is a standardized evidence-based tool that enables non-psychiatrically trained clinicians to identifyand recognize delirium quickly and accurately in both clinical and research settings. Calculated as percentage of the CAM- positive participants

  • Changes in cognitive functioning measured by the Mini-mental state (MMSE) [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    MMSE is a 10-minute bedside measure of impaired thinking. The items of the MMSE include tests of orientation, registration, recall, calculation and attention, naming, repetition, comprehension, reading, writing and drawing.The MMSE changes calculated as between-the-groups means differences, and as percentage of participants who worsened/did not change vs who improved their contitive functioning

  • Changes in physical functioning measured by the 30-second Chair Stand Test [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    The 30-second chair stand test measures body strength, by determining the number of times the participant can stand up fully and sit down in 30 seconds, with the arms crossed over the chest. We have used the modified version of this test, where use of armrest is allowed. The 30-second Chair Stand Test changes calculated as between-the-groups means differences, and as percentage of participants who worsened/did not change vs who improved their physical functioning

  • Changes in Overall Quality of Life (OQoL) measured by the Depression List (DL). [ Time Frame: From the baseline assessment at dag 3 to 10, 30 and 90 days after admission to the rehabilitation unit ]
    DL is an interview-based questionnaire validated among nursing home residents and can be completed by persons themselves with a MMSE score ≥ 5. DL consists of 15 questions covering emotional well-being, social relationships, life-satisfaction, comfort, functional competence, and autonomy. The scale ranges from 0 (best quality of life) to score 30 (poorest quality of life). DL changes calculated as between-the-groups means differences, and as percentage of participants who worsened/did not change vs who improved their OQoL

  • Changes in functional status measured by the ability to live in own home [ Time Frame: Between baseline and 90 after admission to the rehabilitation unit ]
    Percentages participants with change of the residential status

  • Mortality [ Time Frame: At 30 and 90 days after admission to the rehabilitation unit. ]
    Mortality rates calculated as percentages of deaths and hazard ratios

  • Number of ambulatory contacts (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay) ]
    All ambulatory contacts, except to the department of radiology

  • Number of days in hospital (the secondary healthcare utilization) [ Time Frame: At 90 days after admission to the rehabilitation unit ]
    All days spent in hospital

  • Changes in functional status measured by the personal social services extent [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    Percentages of participants with the services

  • Changes in functional status measured by the personal walking aids use [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    Percentages of participants with the walking aid

  • Changes in medication status [ Time Frame: Between baseline and 90 days after admission to the rehabilitation unit ]
    The actual medication usage and the number of Defined Daily Doses within the different The Anatomical Therapeutic Chemical Classification System were clarified and recorded under the personal medication review and through the Electronic Patient Record and the Aarhus Community Care Record by the primary investigator and the research nurse. Percentages of participansts with polyfarmacy. Percentages of participansts with medications older people should avoid or use with caution


Enrollment: 368
Actual Study Start Date: January 17, 2012
Study Completion Date: June 30, 2017
Primary Completion Date: May 29, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Geriatrician-performed CGC
Geriatrician-performed CGC in addition to the usual care at Community Rehabilitation Unit.
Procedure: Geriatrician-performed CGC
Individual disease management and coping was provided using the holistic approach during the face-to-face counselling, where the actual problems, expectations and aims were defined in dialogue with the patient and/or relatives. Afterwards, targeted problem solving with focus on the potentially reversible causes of functional deterioration was established. Finally, medication adjustment was carried out with particular attention to drugs which may lead to iatrogenic functional deterioration, delirium, falls, and malnutrition. Furthermore, the intervention included intravenous antibiotics or blood transfusions (if indicated) conducted by the geriatrician at the rehabilitation units.
No Intervention: Usual care
Usual services at Community Rehabilitation Unit.

  Show Detailed Description

  Eligibility

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.


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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Persons, who received Comprehensive Geriatric Assessment within last 1 month
  2. Persons in the palliative care at the time of referral
  Contacts and Locations
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): NCT01506219


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

Responsible Party: Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01506219     History of Changes
Other Study ID Numbers: NZ-151111-VHDZ
First Submitted: December 28, 2011
First Posted: January 9, 2012
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus ( Aarhus University Hospital ):
Randomized controlled trial
Comprehensive geriatric care
Activity of daily living
Quality of life
Healthcare utilization
Community rehabilitation unit
Medication adjustment