NCT04777136

Brief Summary

The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 16, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

February 16, 2021

Last Update Submit

May 15, 2022

Conditions

Keywords

Geriatric assesmenthip fractureHome-visitOld patients

Outcome Measures

Primary Outcomes (1)

  • Time to contact to the general practitioner or hospital because of a fall

    Fall-related contact for treatment or assessment

    90 days

Secondary Outcomes (17)

  • Contacts to a doctor

    90 days

  • Contacts to a doctor

    30 days

  • Falls

    30 days

  • Falls

    90 days

  • Preventable readmissions

    30 days

  • +12 more secondary outcomes

Study Arms (2)

Geriatric home visit

EXPERIMENTAL

Home-visit where a comprehensive geriatric assessment will be performed

Other: Home visit and comprehensive geriatric assessment

Standard care

ACTIVE COMPARATOR

No follow-up.

Other: Control group, no designated follow up

Interventions

Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions

Geriatric home visit

Only follow-up on patients own initiative with contact to the general practitioner

Standard care

Eligibility Criteria

Age70 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age of 70 years or older
  • Hip fracture
  • Ability to provide informed consent
  • Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk

You may not qualify if:

  • No ability to provide informed consent
  • Patients, who dies within 48 hours of discharge
  • Terminal patients
  • Nursing home residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte hospital

Herlev, Capital Region, 2730, Denmark

Location

MeSH Terms

Conditions

Hip FracturesFrailtyAtrophy

Interventions

House CallsGeriatric AssessmentControl Groups

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services AdministrationData CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthEpidemiologic Research DesignResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Home visit from the geriatric team
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 16, 2021

First Posted

March 2, 2021

Study Start

March 1, 2021

Primary Completion

April 1, 2022

Study Completion

February 28, 2023

Last Updated

May 20, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations