- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04001699
Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity (IPPGA-RCT)
Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity - a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eija Lönnroos, MD, PhD
- Phone Number: +358 40 3552932
- Email: eija.lonnroos@uef.fi
Study Contact Backup
- Name: Kaisa Haatainen
- Email: kaisa.haatainen@kuh.fi
Study Locations
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-
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Kuopio, Finland, FI-70211
- University of Eastern Finland
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Contact:
- Eija Lönnroos, MD, PhD
- Phone Number: +35840 3552932
- Email: eija.lonnroos@uef.fi
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Contact:
- Kaisa Haatainen, PhD
- Phone Number: +35844 717 9322
- Email: kaisa.haatainen@kuh.fi
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
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.
|
Experimental: Intervention
Preoperative assessment conducted by an interprofessional team
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life (15-D)
Time Frame: Preoperative measurement at baseline, postoperative measurements 3 and 9 months after the arthroplasty.
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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
Time Frame: 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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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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eija Lönnroos, University of Eastern Finland, Institute of Public Health and Clinical Nutrition
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HERIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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