- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900804
The Effect of Training Prepared in Line With Fracture Liaison Service Model on Frailty in Hip Surgery Patients
June 9, 2023 updated by: Halise Cinar, Aydin Adnan Menderes University
The Effect of Training Prepared in Line With the Fracture Liaison Service Model in Patients Undergoing Hip Surgery on Patients' Fragility Level, Care Dependence, and Fear of Movement: A Randomized Controlled Study
This study is a randomized controlled experimental research with pretest-posttest control group. The aim of this study is to evaluate the effect of the training prepared in line with the fracture liaison service model on the level of frailty, care dependency and fear of movement in patients undergoing hip surgery. The main questions it aims to answer are as follows:
- Does the training provided to patients undergoing hip surgery in line with the fracture liaison service model have an effect on the level of frailty of patients?
- Does the training provided to patients undergoing hip surgery in line with the fracture liaison service model have an effect on patients' care dependency?
- Does the education given to patients undergoing hip surgery in line with the fracture liaison service model have an effect on patients' fear of movement? It is very important to prevent secondary fractures that may occur in patients undergoing hip surgery. Therefore, the most appropriate prevention interventions to reduce fractures in patients depend on the risk profile and the place of education for hospitalized patients is very important. In this study, Personal Information Collection Form, Patient Follow-up Form, Edmonton Frailty Scale, Causes of Kinesiophobia Scale and Care Dependency Scale will be applied to control and intervention group patients. It is planned to provide training to the intervention group patients in line with the fracture liaison service model. This study will evaluate the effect of the training on patients' level of frailty, care dependency and fear of movement.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The frail patient is a more complex patient group that is difficult for healthcare professionals to monitor and treat.
These patients are more prone to undesirable outcomes such as hospitalization and death.
The risk of frailty increases even more in the elderly population who experience more health problems, especially in the later stages of old age.
In the care of the frail elderly, the nurse, together with the healthcare team, should be able to detect the complications that may develop in the elderly at an early stage, take the necessary precautions and provide services according to the needs.
With the education given in line with the risk factors that occur in frail patients, individuals will be informed about frailty, and at the same time, environmental arrangements, exercises, etc.
It is thought that the immobilization of the patient and the occurrence of secondary fractures will be minimized with such activities.
In order to minimize or prevent possible postoperative complications and to prevent falls and secondary fractures; this study was planned to evaluate the effect of the training prepared in line with the fracture liaison service model on the level of frailty, care dependency and fear of movement in patients undergoing hip surgery.
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halise Cinar
- Phone Number: +905424633771
- Email: halise.cinar@adu.edu.tr
Study Contact Backup
- Name: Nurdan Gezer
- Phone Number: 05069282109
- Email: ngezer@adu.edu.tr
Study Locations
-
-
Aydin
-
Efeler, Aydin, Turkey
- Recruiting
- Aydin Adnan Menderes University
-
Contact:
- Halise Cinar
- Phone Number: +905424633771
- Email: halise.cinar@adu.edu.tr
-
Principal Investigator:
- Halise Cinar
-
Sub-Investigator:
- Nurdan Gezer, Phd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 65 years of age or older
- Being diagnosed with osteoporosis
- Being conscious and able to answer questions
- Not having a problem that would prevent communication
Exclusion Criteria:
- Under 65 years of age with fractures
- Patients with Parkinson's disease
- Patients with visual and hearing impairment
- Patients undergoing hip surgery for the second time
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
|
The Effect of Education Prepared in Line with Fracture Liaison Service Model on Patients' Frailty Level, Care Dependency and Fear of Movement in Hip Surgery Patients
|
|
No Intervention: Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personal Information Collection Form
Time Frame: Baseline
|
The form prepared by the researchers with the support of the literature includes questions about the sociodemographic characteristics of the patients (gender, age, height, weight, educational status, etc.).
This form will be used in the first interview with the patients.
|
Baseline
|
|
Patient Follow-up Form
Time Frame: 3 days after the operation
|
With this form, complications and problems that patients may experience in the postoperative period will be evaluated and the observed complications and problems will be marked on the patient follow-up form.
Patients will be followed up for 3 months with this form
|
3 days after the operation
|
|
Patient Follow-up Form
Time Frame: 3 weeks after the operation
|
With this form, complications and problems that patients may experience in the postoperative period will be evaluated and the observed complications and problems will be marked on the patient follow-up form.
Patients will be followed up for 3 months with this form
|
3 weeks after the operation
|
|
Patient Follow-up Form
Time Frame: 3 months after the operation
|
With this form, complications and problems that patients may experience in the postoperative period will be evaluated and the observed complications and problems will be marked on the patient follow-up form.
Patients will be followed up for 3 months with this form
|
3 months after the operation
|
|
Edmonton Frailty Scale
Time Frame: 3 days after the operation
|
Edmonton Frailty Scale was developed by Rolfson et al. (2006) to assess frailty in elderly individuals.
The scale consists of 9 frailty dimensions included in the Comprehensive Geriatric Assessment and accepted as determinants of frailty.
These frailty dimensions include cognitive status, general health status, functional independence, social support, medication use, nutrition, mood, continence and functional status.
The scale consists of 11 items in total.
The 'clock test' is used to assess cognitive status and the 'Timed Up and Go test' is used to assess functional performance.
|
3 days after the operation
|
|
Edmonton Frailty Scale
Time Frame: 3 weeks after the operation
|
Edmonton Frailty Scale was developed by Rolfson et al. (2006) to assess frailty in elderly individuals.
The scale consists of 9 frailty dimensions included in the Comprehensive Geriatric Assessment and accepted as determinants of frailty.
These frailty dimensions include cognitive status, general health status, functional independence, social support, medication use, nutrition, mood, continence and functional status.
The scale consists of 11 items in total.
The 'clock test' is used to assess cognitive status and the 'Timed Up and Go test' is used to assess functional performance.
|
3 weeks after the operation
|
|
Edmonton Frailty Scale
Time Frame: 3 months after the operation
|
Edmonton Frailty Scale was developed by Rolfson et al. (2006) to assess frailty in elderly individuals.
The scale consists of 9 frailty dimensions included in the Comprehensive Geriatric Assessment and accepted as determinants of frailty.
These frailty dimensions include cognitive status, general health status, functional independence, social support, medication use, nutrition, mood, continence and functional status.
The scale consists of 11 items in total.
The 'clock test' is used to assess cognitive status and the 'Timed Up and Go test' is used to assess functional performance.
|
3 months after the operation
|
|
Causes of Kinesiophobia Scale
Time Frame: 3 days after the operation
|
The Causes of Kinesiophobia Scale (CNS) is a 20-question questionnaire developed by Kocjan and Knapik (2015) to diagnose and determine the causes of motor inactivity.
The CNS consists of a total of 20 questions and two subscales.
|
3 days after the operation
|
|
Causes of Kinesiophobia Scale
Time Frame: 3 weeks after the operation
|
The Causes of Kinesiophobia Scale (CNS) is a 20-question questionnaire developed by Kocjan and Knapik (2015) to diagnose and determine the causes of motor inactivity.
The CNS consists of a total of 20 questions and two subscales.
|
3 weeks after the operation
|
|
Causes of Kinesiophobia Scale
Time Frame: 3 months after the operation
|
The Causes of Kinesiophobia Scale (CNS) is a 20-question questionnaire developed by Kocjan and Knapik (2015) to diagnose and determine the causes of motor inactivity.
The CNS consists of a total of 20 questions and two subscales.
|
3 months after the operation
|
|
Care Dependency Scale
Time Frame: 3 days after the operation
|
The Care Dependency Scale is a scale based on Virginia Henderson's human needs and developed to assess the care dependency status of patients.
The Care Dependency Scale includes various physical and psychological aspects and provides a comprehensive assessment of the patient's care dependency.
This scale was developed by Dijkstra in 1998.
The items included in the scale are nutrition, continence, body posture, mobility, day/night cycle, dressing and undressing, body temperature, body cleanliness, avoiding hazards, communication, communicating with others, worshipping, following rules, daily activities, recreational activities and learning ability.
|
3 days after the operation
|
|
Care Dependency Scale
Time Frame: 3 weeks after the operation
|
The Care Dependency Scale is a scale based on Virginia Henderson's human needs and developed to assess the care dependency status of patients.
The Care Dependency Scale includes various physical and psychological aspects and provides a comprehensive assessment of the patient's care dependency.
This scale was developed by Dijkstra in 1998.
The items included in the scale are nutrition, continence, body posture, mobility, day/night cycle, dressing and undressing, body temperature, body cleanliness, avoiding hazards, communication, communicating with others, worshipping, following rules, daily activities, recreational activities and learning ability.
|
3 weeks after the operation
|
|
Care Dependency Scale
Time Frame: 3 months after the operation
|
The Care Dependency Scale is a scale based on Virginia Henderson's human needs and developed to assess the care dependency status of patients.
The Care Dependency Scale includes various physical and psychological aspects and provides a comprehensive assessment of the patient's care dependency.
This scale was developed by Dijkstra in 1998.
The items included in the scale are nutrition, continence, body posture, mobility, day/night cycle, dressing and undressing, body temperature, body cleanliness, avoiding hazards, communication, communicating with others, worshipping, following rules, daily activities, recreational activities and learning ability.
|
3 months after the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Halise Cinar, Aydin Adnan Menderes University, Turkey
- Study Chair: Nurdan Gezer, Aydin Adnan Menderes University, Turkey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2022
Primary Completion (Estimated)
July 15, 2023
Study Completion (Estimated)
January 15, 2024
Study Registration Dates
First Submitted
April 16, 2023
First Submitted That Met QC Criteria
June 9, 2023
First Posted (Estimated)
June 13, 2023
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Halise03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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