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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04001699
Other study ID # HERIT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 19, 2019
Est. completion date December 31, 2024

Study information

Verified date June 2019
Source University of Eastern Finland
Contact Eija Lönnroos, MD, PhD
Phone +358 40 3552932
Email eija.lonnroos@uef.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Knee and hip arthrosis are common conditions among older adults. Progression of arthrosis often leads to worsening of symptoms and decreased mobility, daily functioning and quality of life. Total joint arthroplasty improves pain in end-stage arthrosis but accustomed postoperative care and rehabilitation alone may not guarantee optimal regain of functioning for frail and vulnerable older arthroplasty patients. Preoperative optimization of older patients with multimorbidity and functional limitations may improve benefits of the arthroplasty even at lower costs. Patients randomized into intervention arm of the present study receive preoperative assessment with treatment and prehabilitation plan. The focuses of the intervention are patient's chronic conditions, nutritional status, medication and physical activity. The intervention is delivered by multiprofessional team (geriatrician, registered nurse, physiotherapist and pharmacist).

Older adults undergoing surgery are a rapidly growing but vulnerable patient group. Knowledge on effects of preoperative evaluation and optimization is sparse, especially on the effects of multi-domain interventions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date December 31, 2024
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 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)

Additional inclusion criteria, at least two of the following:

- 5 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

Exclusion Criteria:

- does not meet the above inclusion criteria

Study Design


Intervention

Other:
Preoperative geriatric assessment
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.

Locations

Country Name City State
Finland University of Eastern Finland Kuopio

Sponsors (2)

Lead Sponsor Collaborator
University of Eastern Finland Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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