NCT04001699

Brief Summary

The objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. The main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 28, 2019

Status Verified

June 1, 2019

Enrollment Period

3.4 years

First QC Date

June 25, 2019

Last Update Submit

June 27, 2019

Conditions

Keywords

preoperativegeriatric assessmentinterprofessional team

Outcome Measures

Primary Outcomes (2)

  • Health-related quality of life (15-D)

    Change in quality of life is measured using the 15-dimensions health-related quality of life questionnaire (15-D) in three time points

    Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.

  • Costs of social and health care services

    Data on the use and costs of social and health care services are obtained from the national and local care registers. The costs of the intervention are evaluated by measuring working time of the inter-professional team members (used per every study patient).

    Changes in costs of care are evaluated for a period starting from one year before and ending two years after the baseline examinations.

Study Arms (2)

Intervention

EXPERIMENTAL

Preoperative assessment conducted by an interprofessional team

Other: Preoperative geriatric assessment

Usual care

ACTIVE COMPARATOR

Usual care

Other: Preoperative geriatric assessment

Interventions

In addition to the usual care, patients randomized to the intervention group receive preoperative assessment conducted by an interprofessional team including geriatrician, registered nurse, physiotherapist and pharmacist. Based on the assessment, a preoperative optimization plan is constructed focusing on the treatment of the patient's chronic conditions, nutritional status, medication and physical activity.

InterventionUsual care

Eligibility Criteria

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

You may qualify if:

  • Place of residence: Kuopio or Vesanto municipality
  • Age ≥ 65 years
  • Clinical decision for knee or hip arthroplasty, elective operation with more than one month waiting time, primary arthroplasty of the index joint.
  • Multimorbidity: the patient has at least two chronic diseases with potential to affect functioning, diseases are defined according to the Function Comorbidity Index (FCI)
  • or more medicines taken regularly (polypharmacy)
  • continuous walking distance less than 500 m
  • needs help in dressing and/or washing oneself
  • needs help when visiting or taking care of businesses outside home
  • body mass index ≤ 23 or ≥ 34

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, FI-70211, Finland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Eija Lönnroos

    University of Eastern Finland, Institute of Public Health and Clinical Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eija Lönnroos, MD, PhD

CONTACT

Kaisa Haatainen

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 28, 2019

Study Start

August 19, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

June 28, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations