NCT02773914

Brief Summary

The study "Comprehensive Geriatric Assessment for frail older people in Swedish acute care settings - a randomized controlled study" comprised two study arms: one intervention and one control group. The aim of the study was to evaluate the effects of the Comprehensive Geriatric Assessment (CGA) for frail older people in Swedish acute hospital settings - the CGA-Swed study. The intervention group received the CGA and a control group received medical assessment without the CGA. Follow-ups were conducted after 1, 6 and 12 months, with dependence in activities of daily living (ADL) as the primary outcome measure. The study group consisted of frail older people, 75 years and older, in need of acute medical hospital care. The study design, randomization and process evaluation carried out were intended to ensure the quality of the study. Baseline data showed that the randomisation was successful and that the sample included frail older people with high dependence in ADL, and with a high comorbidity. Thus, the CGA contributed to early recognition of frail older people's needs and ensured a care plan and follow-up. When investigating the long-term effects on frail older people's ADL 12 months after receiving the CGA, results showed that twelve participants in the intervention group (15.4%), and four participants in the control group (5.2%) had improved in their ADL 1 year after discharge. Qualitative interviews with CGA-participants also showed that the participants felt respected as a person when receiving care on a CGA acute geriatric ward.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2020

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

November 18, 2024

Completed
Last Updated

November 18, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

May 9, 2016

Results QC Date

August 22, 2022

Last Update Submit

September 12, 2024

Conditions

Keywords

Activity of Daily Living (ADL)Comprehensive Geriatric AssessmentElderlyFrailtyRandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • Dependence in Activities of Daily Living

    Changes in number of person dependent in one or more daily activity from baseline to follow-up. Dependence in daily activities was measured using the ADL-staircase assessment by combining both interviews and observations. It includes dependence in nine activities: cleaning, shopping, transportation, cooking, bathing, dressing, going to the toilet, transferring and feeding. Dependence was defined as a state in which another person is involved in the activity by giving personal or directive assistance. The sum of dependence in the nine activities of daily living is calculated, range 0-9, with a clinically significant change of ≥1 unit between baseline and follow-up. At baseline, personal ADL (PADL: bathing, dressing, going to the toilet, transferring and feeding) was inquired for both actual PADL status during the hospital stay and retrospectively for PADL before onset of the acute illness leading to the hospital admission.

    1 year

Secondary Outcomes (3)

  • Self-rated Health

    1 year

  • Satisfaction With Quality of Care

    1 month follow-up

  • Life Satisfaction

    1 year

Study Arms (2)

CGA intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Comprehensive Geriatric Assessment intervention

CGA intervention

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isabelle Andersson Hammar

Gothenburg, Sweden

Location

Related Publications (7)

  • Andersson Hammar I, Westgard T, Dahlin-Ivanoff S, Wilhelmson K. Frail older people with decreased cognition can perceive reduced self-determination in self-care and social relationships. BMC Geriatr. 2024 Jan 3;24(1):7. doi: 10.1186/s12877-023-04492-y.

  • Westgard T, Hammar IA, Wilhelmson K, Waern M. Comprehensive geriatric assessment is associated with increased antidepressant treatment in frail older people with unplanned hospital admissions-results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Aug 5;22(1):645. doi: 10.1186/s12877-022-03324-9.

  • Wilhelmson K, Andersson Hammar I, Westgard T, Holmquist Henrikson L, Dahlin-Ivanoff S. Positive effects on activities of daily living one year after receiving comprehensive geriatric assessment - results from the randomised controlled study CGA-Swed. BMC Geriatr. 2022 Mar 3;22(1):180. doi: 10.1186/s12877-022-02862-6.

  • Wilhelmson K, Hammar IA, Ehrenberg A, Niklasson J, Eckerblad J, Ekerstad N, Westgard T, Holmgren E, Aberg ND, Ivanoff SD. Comprehensive Geriatric Assessment for Frail Older People in Swedish Acute Care Settings (CGA-Swed): A Randomised Controlled Study. Geriatrics (Basel). 2020 Jan 24;5(1):5. doi: 10.3390/geriatrics5010005.

  • Westgard T, Andersson Hammar I, Dahlin-Ivanoff S, Wilhelmson K. Can Comprehensive Geriatric Assessment Meet Frail Older People's Needs? Results from the Randomized Controlled Study CGA-Swed. Geriatrics (Basel). 2020 Dec 4;5(4):101. doi: 10.3390/geriatrics5040101.

  • Westgard T, Wilhelmson K, Dahlin-Ivanoff S, Ottenvall Hammar I. Feeling Respected as a Person: a Qualitative Analysis of Frail Older People's Experiences on an Acute Geriatric Ward Practicing a Comprehensive Geriatric Assessment. Geriatrics (Basel). 2019 Jan 25;4(1):16. doi: 10.3390/geriatrics4010016.

  • Westgard T, Ottenvall Hammar I, Holmgren E, Ehrenberg A, Wisten A, Ekdahl AW, Dahlin-Ivanoff S, Wilhelmson K. Comprehensive geriatric assessment pilot of a randomized control study in a Swedish acute hospital: a feasibility study. Pilot Feasibility Stud. 2018 Jan 29;4:41. doi: 10.1186/s40814-018-0228-1. eCollection 2018.

MeSH Terms

Conditions

Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Isabelle Andersson Hammar
Organization
Göteborg University

Study Officials

  • Isabelle Andersson Hammar, Assoc.prof

    Göteborg University

    PRINCIPAL INVESTIGATOR
  • Katarina Wilhelmson, Professor

    Göteborg University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 16, 2016

Study Start

March 1, 2016

Primary Completion

January 27, 2020

Study Completion

January 27, 2020

Last Updated

November 18, 2024

Results First Posted

November 18, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations