The Effect of Post-discharge educatıon provıded vıa Tele-nursıng to Elderly patıents

February 5, 2024 updated by: HASRET YALÇINÖZ BAYSAL

The Effect of Post-discharge Education Provided Via Tele-nursing to Elderly Patients Who Had Surgery Due to Hip Fracture, on the Quality of Life and Functional Independence Levels of the Patients

Purpose: The aim of this study is to evaluate the effect of post-discharge training given via tele-nursing to elderly patients operated for hip fracture on the quality of life and functional independence levels of the patients.

Study Overview

Status

Status

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

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

Materials and Methods: This randomized controlled, pretest-posttest, single-center experimental study was conducted in a hospital between August 2022 and April 2023, with 30 patients in the intervention group and 30 patients in the control group. Nursing intervention was administered to the intervention group by three educational online video calls (1st, 2nd and 3rd weeks after discharge), three educational voice phone calls (4th, 5th and 6th weeks after discharge) and It consists of a training booklet with educational content. No intervention was applied to the control group. Research data; It was collected using the Patient Introduction Form, SF-36, FIM. Informed consent was obtained from the patients and caregivers with the permission of the ethics committee and the institution. Data analysis was done using Chi-Square, Independent T-Test and Dependent T-Test.

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 (Actual)

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.
60

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 Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University

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:

  • Being 65 years or older
  • Being hospitalized and operated on with a diagnosis of hip fracture as a result of a simple fall/falling from one's own level/osteoporotic fracture
  • Being literate
  • Not having a visual/hearing disability that would hinder communication.
  • Not having a Mental Disorder (According to the statements of the patients)
  • Having a primary caregiver aged 18 and over who will cooperate throughout the research,
  • Having any of the available technical equipment that allows online calls (Phone, tablet, computer, etc.).

Exclusion Criteria:

  • • Having previously broken a hip and been operated on

    • Being bedridden or using walking aids before the current fracture

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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.
No Intervention: Control
No intervention was made
Experimental: Education provided via TeleNursing
Nursing intervention consists of 3 online video calls with educational content to the intervention group (1st, 2nd and 3rd weeks after discharge), 3 audio phone calls (4th, 5th and 6th weeks after discharge) and an educational booklet.
Behavioral: Education provided via TeleNursing

Online Video Call Online video interviews were conducted with the patients in the intervention group once in the first week (day 1-7), once in the second week (day 8-14) and once in the third week, using mobile phone programs and/or computer programs that provide video conversation opportunities. It was conducted in the form of remote online video calls, held three times in total, once within the 15-21st day.

Voice Phone Call After audio telephone interviews and online video interviews were completed within the first three weeks after the patients in the intervention group were discharged; It was carried out using a mobile phone 3 times in total: once in the fourth week (day 22-28), once in the fifth week (day 29-35) and once in the sixth week (day 36-42).

Other Names:
  • Online Video Call and Voice Phone Call

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
Quality of Life Scale
Time Frame: up to 7 weeks
The scale consists of 36 items; 8 sub-dimensions as "physical function, social function, physical role limitation, emotional role limitation, mental health, vitality (energy, liveliness, vitality), pain and general health perception"; It is a multi-headed scale that includes two main dimensions: "physical and mental".Total score is not obtained from the scale. Evaluation is made based on the scores obtained separately for each subscale. The highest score that can be obtained for each question of the scale, 100, indicates good health status and increased health-related quality of life; The lowest score, 0, indicates poor health status and decreased health-related quality of life. The total score of the sub-dimensions is obtained by dividing the sum of the corresponding scores for each question of the scale items by the number of items.
up to 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Independence Scale
Time Frame: up to 7 weeks
It determines the individual's degree of independence in physical and cognitive activities. The Functional Independence Scale consists of 18 items and measures in 2 areas: physical (motor) and cognitive.While physical function has 13 items, cognitive function domain has 5 items. Each item is evaluated between 1 and 7 points, with 1 point indicating complete dependence and 7 points indicating complete independence.
up to 7 weeks

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.
HASRET YALÇINÖZ BAYSAL

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: Hasret Yalcinoz Baysal, Associate Prof, Ataturk University

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.
March 25, 2021

Primary Completion (Actual)

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.
April 1, 2023

Study Completion (Actual)

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.
December 14, 2023

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).
December 22, 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.
February 5, 2024

First Posted (Actual)

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.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

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.
February 14, 2024

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.
February 5, 2024

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.
February 1, 2024

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.
  • HYALCINOZBAYSAL

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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