NCT01506219

Brief Summary

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 outpatient 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 an outpatient 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 17, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2015

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

January 23, 2018

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

December 28, 2011

Last Update Submit

January 18, 2018

Conditions

Fragility

Keywords

Randomized controlled trialComprehensive geriatric careActivity of daily livingQuality of lifeHealthcare utilizationCommunity rehabilitation unitMedication adjustment

Outcome Measures

Primary Outcomes (1)

  • Number of hospital admissions and ED visits (the secondary healthcare utilization)

    Numbers of all hospital admissions and ED visits

    At 90 days after admission to the rehabilitation units

Secondary Outcomes (14)

  • Number of ambulatory contacts (the secondary healthcare utilization)

    At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)

  • Number of days in hospital (the secondary healthcare utilization)

    At 90 days after admission to the rehabilitation unit

  • Number of GP contacts (the primary healthcare utilization)

    At 90 days after admission to the rehabilitation unit (during + after the rehabilitation stay)

  • Mortality

    At 30 and 90 days after admission to the rehabilitation unit.

  • Changes in ADL measured by the Modified Barthel-100 Index (MBI)

    From the baseline assessment at day 3 to 10, 30 and 90 days after admission to the rehabilitation unit

  • +9 more secondary outcomes

Study Arms (2)

Geriatrician-performed CGC

EXPERIMENTAL

Geriatrician-performed CGC in addition to the usual care at Community Rehabilitation Unit.

Procedure: Geriatrician-performed CGC

Usual care

NO INTERVENTION

Usual services at Community Rehabilitation Unit.

Interventions

Geriatrician-performed CGCPROCEDURE

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.

Geriatrician-performed CGC

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Persons, who received Comprehensive Geriatric Assessment within last 1 month
  • Persons in the palliative care at the time of referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Geriatrics, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Rehabilitation Unit Vikaergaarden and Thorsgaarden

Aarhus, 8240, Denmark

Location

Related Publications (1)

  • Zintchouk D, Gregersen M, Lauritzen T, Damsgaard EM. Geriatrician-performed comprehensive geriatric care in older adults referred to an outpatient community rehabilitation unit: A randomized controlled trial. Eur J Intern Med. 2018 May;51:18-24. doi: 10.1016/j.ejim.2018.01.022. Epub 2018 Feb 1.

    PMID: 29395938DERIVED

Study Officials

  • Dmitri Zintchouk, MD

    Department of Geriatrics, Aarhus University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Else Marie Damsgaard, MD, DMSc

    Department of Geriatrics, Aarhus University Hospital, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pragmatic open assessor-blinded clinical randomized controlled trial with two parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2011

First Posted

January 9, 2012

Study Start

January 17, 2012

Primary Completion

May 29, 2015

Study Completion

June 30, 2017

Last Updated

January 23, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)