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Comprehensive Geriatric Assessment for Frail Older People

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ClinicalTrials.gov Identifier: NCT02773914
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
Umeå University
Information provided by (Responsible Party):
Göteborg University

Study Description
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Brief Summary:

The present study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprises two study arms: one intervention and one control group. It is a multicentre trial with 5 centres with diverse local conditions in different parts of Sweden, with an implementation study alongside.

The intervention "Comprehensive Geriatric Assessment (CGA) for frail older people" addresses people 75 years and older who are seeking acute hospital care at the hospital emergency department, and who are identified as frail. The CGA intervention, including a multidisciplinary team that assesses the patients socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up, contributes to a person-centred, and a comprehensive assessment tailored for each person. The results of this study are expected to optimize the implementation of future complex interventions and lead to the improvement of the care, support and rehabilitation for frail older people with complex needs.

This study will contribute to an evidence base for full scale implementation of CGA in Swedish hospital care. The process evaluation, aiming to provide insight into function and consequences of the intervention, why it works or fails, is an important part of the design that will contribute with insights into real life conditions that may be challenging in implementing CGA. The investigators will evaluate fidelity and quality of the implementation, clarify causal mechanisms and identify contextual factors associated with variation in outcomes. The development of screening for frailty and CGA are potential and important tools to identify needs of this older population, and to direct the right health care actions towards those in most need.

The study will address the following research questions:

  1. Can Comprehensive Geriatric Assessment for frail older patients in Swedish acute hospital settings:

    • increase/maintain independence, functional status, health related quality of life and life satisfaction?
    • increase satisfaction with health care?
    • reduce health care consumption?
  2. How feasible and acceptable are the study processes and procedures of CGA from the perspective of care givers and older persons in Swedish settings?

Condition or disease Intervention/treatment Phase
Dependency Other: Comprehensive Geriatric Assessment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings: A Randomized Controlled Study
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arms and Interventions
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Arm Intervention/treatment
Experimental: CGA intervention
The CGA intervention will include multidisciplinary teams consisting of physician, nurse (RN), physiotherapist (PT), occupational therapist (OT) and social worker (SW). The team will work according to CGA, and have the primary and continuing responsibility for planning of hospital care and discharge. CGA will include assessment of socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, as well as treatment and planning for discharge and follow-up.
 Other: Comprehensive Geriatric Assessment
Comprehensive Geriatric Assessment intervention
No Intervention: Control group
The control group receives usual hospital care, that is care given at an ordinary medical hospital ward, without the specialized multi-disciplinary team approach and CGA.


Outcome Measures
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Primary Outcome Measures :
  1. Dependence in Activities of Daily Living (ADL-staircase) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
    Changes in number of person dependent in one or more daily activity from baseline to follow-up.


Secondary Outcome Measures :
  1. Capability (ICECAP-O) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
    Changes in scores of ICECAP-O from baseline to follow-up.

  2. Self-rated Health (SF-36) [ Time Frame: Baseline, 1-month follow-up, 6-month follow-up and 12-month follow-up ]
    Changes in number of person with good self-rated health from baseline to follow-up.

  3. Satisfaction with quality of care (Questionnaire) [ Time Frame: 1-month follow-up ]
    Number of persons satisfied with quality of care


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients 75 years and older seeking acute hospital care at the hospital emergency department will be screened for frailty.

Exclusion Criteria:

  • Those with symptoms of predefined diagnoses such as stroke, acute myocardial infarction and hip fractures, admitted through "fast tracks" directly to a designated ward without passing the emergency department.
Contacts and Locations
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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): NCT02773914


Contacts
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Contact: Isabelle Ottenvall Hammar +46 (0) 31-786 57 88

Locations
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Sweden
Gothenburg University Recruiting
Gothenburg, Sweden
Contact: Isabelle Ottenvall Hammar         
Sponsors and Collaborators
Göteborg University
Umeå University
Investigators
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Principal Investigator: Isabelle Ottenvall Hammar, Sahlgrenska Akademin Göteborgs Universitet Institute of Neuroscience and Physiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02773914    
Other Study ID Numbers: CGA for frail older people
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Göteborg University:
Activity of Daily Living (ADL)
Comprehensive Geriatric Assessment
Elderly
Frailty
Randomized controlled study