NCT06284759

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

February 9, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

Activities of Daily LivingOrem's Self Care TheoryTrauma NursingTele-nursingLower extremity fracture surgerySelf care agencyOrthopaedic and trauma nursing

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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.

Study Arms (2)

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.

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.).

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, 06510, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In the study, the statistician was blinded using the blind technique.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 29, 2024

Study Start

September 15, 2023

Primary Completion

March 28, 2024

Study Completion

March 28, 2024

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations