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Comprehensive Geriatric Assessment in Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Comprehensive geriatric assessment
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both genders Age > 70 years; able to sign the informed consent Diagnosis of knee OA according to standardized criteria in Grade 1 (doubtful narrowing of joint space and possible osteophytic lipping), Grade 2 (definite osteophytes and possible narrowing of joint space) Kellgren and Lawrence system or Grade 3 (moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends). Exclusion Criteria: Expected life expectancy less than 6 months Previous orthopedic surgery, in the three months before the enrolment or a planned orthopedic intervention in the next 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Comprehensive Geriatric Assessment

    Controls

    Arm Description

    This group will receive a comprehensive geriatric assessment evaluation during the study, using the multidimensional prognostic index

    This group will receive standard/usual care

    Outcomes

    Primary Outcome Measures

    Change in pain, physical function, stiffness
    We will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The WOMAC, that is one of the most used tool in knee OA research, measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The single items of the WOMAC will be assessed as co-primary outcomes.

    Secondary Outcome Measures

    Change in the adherence to medications
    Adherence to medications suggested during the first visit will be evaluated during the follow-up period using questionnaires.
    Change in the severity of multidimensional frailty
    This outcome will be explored using the multidimensional prognostic index (MPI), a scale that measures eight different domains typical of older people. The sum of the calculated scores from the eight domains will be divided by 8 to obtain a final MPI risk score ranging from 0 = no risk to 1 = higher risk of mortality.
    Change in the quality of life
    The short form 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the less quality of life.

    Full Information

    First Posted
    December 3, 2022
    Last Updated
    December 13, 2022
    Sponsor
    University of Palermo
    Collaborators
    Charles University, Czech Republic, Ente Ospedaliero Ospedali Galliera, St. Marien-Hospital Düren, Erasmus University Rotterdam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05659979
    Brief Title
    Comprehensive Geriatric Assessment in Knee Osteoarthritis
    Official Title
    The Role of Comprehensive Geriatric Assessment in Older Patients Affected by Knee Osteoarthritis: an Exploratory Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Palermo
    Collaborators
    Charles University, Czech Republic, Ente Ospedaliero Ospedali Galliera, St. Marien-Hospital Düren, Erasmus University Rotterdam

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Osteoarthritis (OA) is the most common form of arthritis, and is characterized by joint pain and stiffness leading to functional decline and relevant loss in quality of life. The management of knee OA is demanded to several specialists, including general practitioners, rheumatologists, orthopedics and finally geriatricians. However, the exact role of geriatricians in the management of knee OA was poorly studied, whilst the comprehensive geriatric assessment (CGA) is widely used for preventing negative consequences in older people.
    Detailed Description
    Osteoarthritis (OA) is the most common form of arthritis, and is characterized by joint pain and stiffness leading to functional decline and relevant loss in quality of life. The incidence of OA is rising due to the aging population and an increase in some risk factors, such as obesity. Knee OA is the most common OA localization, and symptomatic knee OA is highly prevalent among people aged over 50 years, affecting more than 250 million people worldwide. Knee OA is a leading cause of pain in older people, and pain of the hip and knee results in physical disability and an increased risk of all-cause mortality. Hip and knee OA together are the eleventh highest contributor to global disability: the years of life lived with OA-related disability increased by 64% from 1990 to 2010 reaching 17 million. OA is a progressive disorder, with different degrees of severity, that requires long-term management with various treatment options over the course of the disease. The goals of treatment for OA are to reduce symptoms and ultimately slow disease progression, which may in turn reduce the impact of OA on the patient's mobility and quality of life, with consequent reduction in healthcare resource needs. In 2019, the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) published recommendations for the management of knee OA in the form of a treatment algorithm that provides practical guidance for the prioritization of interventions and guides physicians through progressive, logical steps based on the severity of the knee OA signs/symptoms. The management of knee OA is therefore demanded to several specialists, including general practitioners, rheumatologists, orthopedics and finally geriatricians. However, the exact role of geriatricians in the management of knee OA was poorly studied, whilst the comprehensive geriatric assessment (CGA) is widely used for preventing negative consequences in older people, such as hospitalization or mortality. Moreover, CGA can be used across different settings, from primary care to hospital, with similar beneficial effects in older people. Finally, people affected by knee OA are usually affected by other medical (e.g., dementia, cardiovascular diseases, depression) and non-medical (e.g., loneliness) conditions that can limit the adherence to therapeutic approaches, therefore limiting the efficacy of the interventions suggested in knee OA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Comprehensive Geriatric Assessment
    Arm Type
    Experimental
    Arm Description
    This group will receive a comprehensive geriatric assessment evaluation during the study, using the multidimensional prognostic index
    Arm Title
    Controls
    Arm Type
    No Intervention
    Arm Description
    This group will receive standard/usual care
    Intervention Type
    Other
    Intervention Name(s)
    Comprehensive geriatric assessment
    Intervention Description
    A detailed comprehensive geriatric assessment will be given to all the participants randomized to this group, including the administration of multidimensional prognostic index (MPI), a tool derived from the CGA and consisting of eight different domains.
    Primary Outcome Measure Information:
    Title
    Change in pain, physical function, stiffness
    Description
    We will use the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale. The WOMAC, that is one of the most used tool in knee OA research, measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The single items of the WOMAC will be assessed as co-primary outcomes.
    Time Frame
    Baseline, 3 months, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in the adherence to medications
    Description
    Adherence to medications suggested during the first visit will be evaluated during the follow-up period using questionnaires.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Change in the severity of multidimensional frailty
    Description
    This outcome will be explored using the multidimensional prognostic index (MPI), a scale that measures eight different domains typical of older people. The sum of the calculated scores from the eight domains will be divided by 8 to obtain a final MPI risk score ranging from 0 = no risk to 1 = higher risk of mortality.
    Time Frame
    Baseline, 3 months, 6 months
    Title
    Change in the quality of life
    Description
    The short form 36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the less quality of life.
    Time Frame
    Baseline, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Both genders Age > 70 years; able to sign the informed consent Diagnosis of knee OA according to standardized criteria in Grade 1 (doubtful narrowing of joint space and possible osteophytic lipping), Grade 2 (definite osteophytes and possible narrowing of joint space) Kellgren and Lawrence system or Grade 3 (moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends). Exclusion Criteria: Expected life expectancy less than 6 months Previous orthopedic surgery, in the three months before the enrolment or a planned orthopedic intervention in the next 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicola Veronese, MD
    Phone
    0916558519
    Email
    nicola.veronese@unipa.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicola Veronese, MD
    Organizational Affiliation
    University of Palermo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comprehensive Geriatric Assessment in Knee Osteoarthritis

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