NCT05900804

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

April 16, 2023

Last Update Submit

June 9, 2023

Conditions

Keywords

NursingFrailtyEducationFracture Liaison Services

Outcome Measures

Primary Outcomes (13)

  • Personal Information Collection Form

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL

* 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

Control group

NO INTERVENTION

* 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.

Interventions

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

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • Being diagnosed with osteoporosis
  • Being conscious and able to answer questions
  • Not having a problem that would prevent communication

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydin Adnan Menderes Üniversity

Efeler, Aydın, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Halise Cinar

    Aydin Adnan Menderes University, Turkey

    PRINCIPAL INVESTIGATOR
  • Nurdan Gezer

    Aydin Adnan Menderes University, Turkey

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2023

First Posted

June 13, 2023

Study Start

November 15, 2022

Primary Completion

July 15, 2023

Study Completion

January 15, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations