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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Aydin
      • Efeler, Aydin, Turkey
        • Recruiting
        • Aydin Adnan Menderes University
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
  • On the 3rd postoperative day, patient information form, patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied in the patient room. Afterwards, the training prepared in line with the fracture liaison service model will be verbally explained to the patients and then the booklet prepared by taking expert opinion will be given to the patients.
  • 3rd week patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied in orthopedics and traumatology outpatient clinic.
  • 3rd month patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied at home visit.
Other: Training Prepared in Line with the Fracture Liaison Service Model
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
  • On the 3rd postoperative day, patient information form, patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied in the patient room.
  • Week 3 patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied in orthopedics and traumatology outpatient clinic.
  • 3rd month patient follow-up form, Edmonton frailty scale, kinesiophobia causes scale and care dependency scale will be applied at home visit. Afterwards, the training prepared in line with the fracture liaison service model will be verbally explained to the patients and then the booklet prepared by taking expert opinion will be given to the patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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