Lower Extremity FractureNCT06284759
The Effect of Tele-Nursing Application on Self-Care Ability and Daily Living Activities in Fracture Surgery Patients
A study testing post-discharge telenursing intervention in people with Lower Extremity Fracture, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Fracture
- What is being tested?
- post-discharge telenursing intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Extremity Fracture
- Being tested
- post-discharge telenursing intervention
- Keywords
- Activities of Daily Living, Orem's Self Care Theory, Trauma Nursing, Tele-nursing, Lower extremity fracture surgery, Self care agency, Orthopaedic and trauma nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-discharge telenursing interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: post-discharge telenursing intervention |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Self Care, Assessed using the Self-Care Agency scale.
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.
Measured: 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.
Activities of daily living, Assessed using the Katz index of independence in activities of daily living (ADL) scale.
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.
Measured: 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.
Instrumental activities of daily living, Assessed using the The Lawton instrumental activities of daily living scale.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Sep 2023
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Lokman Hekim University, Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Sevil Güler, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284759
- Sponsor's protocol ID
- E-77082166-302.08.01-380534
- Status last verified
- Dec 2024
- First submitted
- 9 Feb 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06284759
- Acronym / sponsor ID
- E-77082166-302.08.01-380534
- Conditions
- Lower Extremity Fracture
- Keywords
- Activities of Daily Living, Orem's Self Care Theory, Trauma Nursing, Tele-nursing, Lower extremity fracture surgery, Self care agency, Orthopaedic and trauma nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Lokman Hekim University, Ankara City Hospital Bilkent
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: post-discharge telenursing interventionPatients 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. |
| Control | No intervention | –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.). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post-discharge telenursing interventionTele-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. | Other | Intervention |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-discharge telenursing intervention in people with Lower Extremity Fracture, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.