- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06284759
The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients
December 3, 2024 updated by: Sevil Güler, Gazi University
The Effect of Tele-Nursing Application Based on Orem's Self-Care Theory on Self-Care Ability and Daily Living Activities in Trauma-Related Lower Extremity Fracture Surgery Patients
This study aims to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research was conducted to determine the effect of tele-nursing application based on Orem's Self-care Theory on self-care agency and daily living activities in trauma-related lower extremity fracture surgery patients.
The research was planned as a randomized controlled experimental type study.
52 patients (intervention 26, control 26) were included in the study sample using the "simple randomization method".
In order to collect the data, Introductory Information Form, Self-Care Agency Scale, KATZ Activities of Daily Living Scale and Lawton Brody Activities of Daily Living Scale were used.
Current hospital procedures were applied to patients in the control group without any intervention.
Patients in the intervention group were monitored with a tele-nursing application based on Orem's Self-Care Theory, and training and counseling were provided for 6 weeks after discharge.
Data; It was collected face to face once before discharge in both groups, and three times by video conference method: 7-10 days, 18-21 days and 40-45 days after discharge.
Tele-Nursing Application Monitoring Form and reminder infographics, prepared based on Orem's Self-Care Theory, were used in the follow-up process of patients who had trauma-related lower extremity fracture surgery.
Chi square, independent samples t test, analysis of variance in repeated measurements and Pearson correlation analysis were used to analyze the data.
While there was no statistical difference between the groups in the first measurements, in the 2nd, 3rd and 4th measurements, the intervention group's self-care agency, KATZ activities of daily living and Lawton Brody instrumental activities of daily living scale scores were found to be statistically significantly higher than the control group (p<0, 05).
In this study, it was concluded that tele-nursing application based on Orem Self-Care Theory has a positive effect on self-care agency and daily life activities.
Study Type
Interventional
Enrollment (Actual)
52
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 Locations
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Ankara, Turkey, 06510
- Lokman Hekim University
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Between the ages of 18-65,
- Agreeing to participate in the study voluntarily,
- Able to understand and speak Turkish,
- At least primary school graduate,
- Those who have undergone lower extremity fracture surgery,
Exclusion Criteria:
- Over 65 years of age,
- Having an uncontrollable medical problem,
- Having a hip fracture or fragility fracture due to a fall,
- Having an external fixator,
- Amputation develops,
- People whose speech, hearing and visual disabilities prevent them from participating in telenursing monitoring will not be included in the study.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Patients in the intervention group were monitored with a tele-nursing application based on Orem's Self-Care Theory, and training and counseling were provided for 6 weeks after discharge.
Post-discharge interviews were conducted by resercher via phone call and video conference (zoom, WhatsApp, etc.).
The video conference method was presented to the patient's preference and the decision was made together.
The interview with each patient lasted an average of 30 minutes.
Patients in the intervention group were sent infographics prepared in line with the theory, including the interview content and suggestions after each interview.
The study focuses on post-discharge tele-nursing practice follow-up outcomes.
Baseline data were collected at the hospital on the 2nd and 3rd postoperative day.
Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
|
Tele-nursing based on Orem's Self-Care Theory was applied to patients with lower extremity fracture surgery.
Phone/video calls 24-48 after discharge.
hours, 7-10.
day,18-21.
day, 28-30th day and 40-45th day.
day was made.
Telephone or video conference interviews were held on the day and time convenient for the patient.
After each meeting, the date and time of the next meeting was planned.
The video conferencing method (zoom, skype, whatsapp, etc.) was presented to the patient's preference and the decision was made together.
In phone/video conference calls, patients were informed about their current problems.
Additionally, patients' questions were answered.
Prior to tele-nursing monitoring, the researchers identified emergent or urgent situations; Patients were informed that they should consult their doctor if this occurs.
The interview with each patient lasted an average of 30 minutes.
|
|
No Intervention: Control
Patients in the control group were discharged in accordance with the current hospital procedure.
No intervention was made.
The study focuses on post-discharge tele-nursing practice follow-up outcomes.
Baseline data were collected at the hospital on the 2nd and 3rd postoperative day.
Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
It was collected by phone call or video conference (zoom, WhatsApp, etc.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Care, Assessed using the Self-Care Agency scale.
Time Frame: Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
|
The scale is a 5-point Likert-type and each statement is scored from 0 to 4. Among the response options, 0 points are given to the answer "It doesn't describe me at all", 1 point is given to the others, respectively, "It doesn't describe me much", 2 points are given to "I have no idea", 3 points are given to the answer "It describes me a little" and 4 points are given to the answer "It describes me a lot".
In the Turkish-translated scale, 8 items (items 3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed.
The maximum score is 140.
A high score from the scale indicates the high level of self-care or self-care ability and strength of the individual.
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Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
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|
Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale.
Time Frame: Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
|
The scale measures the degree of addiction in self-care activities, which consists of six headings: bathing, dressing, toilet needs, mobility, excretion and nutrition.
The total score from the scale varies between 0-6.
A low score indicates a high level of addiction.
According to the results of the Katz Activities of Daily Living Scale, 0-2 points are classified as dependent, 3-4 points are classified as semi-dependent, and 5-6 points are classified as independent.
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Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
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|
Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale.
Time Frame: Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
|
The scale consists of a total of 8 items and a single sub-dimension, including the ability to use the phone, shopping, meal preparation, house cleaning, laundry, travel, responsibility for taking medications, and financial affairs.
The total score from the scale varies between 0-8.
A low score indicates a high level of addiction.
|
Baseline data were collected at the hospital on the 2nd and 3rd postoperative day. Post-discharge data were collected on the 7th-10th day, 18th-21st day and 40th-45th day.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 15, 2023
Primary Completion (Actual)
March 28, 2024
Study Completion (Actual)
March 28, 2024
Study Registration Dates
First Submitted
February 9, 2024
First Submitted That Met QC Criteria
February 28, 2024
First Posted (Actual)
February 29, 2024
Study Record Updates
Last Update Posted (Estimated)
December 5, 2024
Last Update Submitted That Met QC Criteria
December 3, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-302.08.01-380534
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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