NCT06130098

Brief Summary

To examine the effect of education and consultancy provided via telenursing service after total knee arthroplasty on postoperative quality of life and some complications.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 6, 2023

Last Update Submit

November 11, 2023

Conditions

Keywords

total knee replacementtelenursingpost-discharge care

Outcome Measures

Primary Outcomes (1)

  • OXFORD KNEE SCORE

    To evaluate the gains in daily life and the change in the health of patients who haveundergone TKA surgery after surgery.The scoring system is a 12-item self-reported measurement tool to evaluate physical function and pain in patients with total knee arthroplasty. After this scoring system is applied, the answers given by the patients are scored between 0 and 4. In total, a patient can get a minimum of 0 and a maximum of 48 points. For results, 0-19 points are considered excellent, 20-29 points are good, 30-39 points are fair, and 40-48 points are considered poor.

    at the end of the fourth and sixth weeks

Secondary Outcomes (1)

  • EQ-5D-5L quality of life scale

    at the end of the fourth and sixth weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Training by the clinical nurse before discharge. Prepare an educational brochure and give it to patients. Application of patient information form, EQ-5D-5L Quality of Life and Oxford Knee Score Scale During the routine check-up in the first week, evaluates the development of complications without knowing which group the patient is in. Within the first week and at the end of the fourth week, the wound site is evaluated by the physician for the development of complications, . Patients who cannot come for a check-up should send a photo of the wound area to the researcher via WhatsApp application, and the photo will be forwarded to the clinician who performed the surgery and the physician will record the complication situation. It is planned to receive complication development and wound site evaluation results from the physician system. At the end of the fourth and sixth weeks after discharge, the EQ-5D-5L and OKS scale must be filled in again by the patients.

Other: control group

experimental group

ACTIVE COMPARATOR

Active Comparator: experimental group Providing education to patients by preparing a pre-discharge education brochure. You will be contacted by phone at the end of the first, second, third and fourth weeks after discharge. Application of the patient information form, EQ-5D-5L Quality of Life and Oxford Knee Score Scale. Evaluation of the wound site in terms of complications at the end of the first and fourth weeks. It is planned to receive complication development and wound site evaluation results from the system. After the first check-up, a call is made at the end of the first week after discharge. Providing training on the subjects included in the training brochure during the first phone call In the fourth meeting, tele-nursing service was provided through the "Telephone Counseling Protocol" Refilling of the EQ-5D-5L quality of life and Oxford Knee Score scale by patients at routine check-up at the end of the fourth and sixth weeks after discharge

Other: experimental group

Interventions

Training by the clinical nurse before discharge. Prepare an educational brochure and give it to patients. Application of patient information form, EQ-5D-5L Quality of Life and OKS Scale During the routine check-up in the first week, evaluates the development of complications without knowing which group the patient is in. Within the first week and at the end of the fourth week, the wound site is evaluated by the physician for the development of complications, . Patients who cannot come for a check-up should send a photo of the wound area to the researcher via WhatsApp application, and the photo will be forwarded to the clinician who performed the surgery and the physician will record the complication situation. It is planned to receive complication development and wound site evaluation results from the physician system. At the end of the fourth and sixth weeks after discharge, the EQ-5D-5L and OKS scale must be filled in again by the patients.

control group

Providing training before discharge Prepare an educational brochure and give it to patients. You will be contacted by phone at the end of the first, second, third and fourth weeks after discharge. Application of patient information form, EQ-5D-5L Quality of Life and OKS Scale Evaluating the wound site in terms of complications within the first week and at the end of the fourth week. It is planned to receive complication development and wound site evaluation results from the system. After the first check-up, calling the patients in the study group at the end of the first week after discharge. Providing training on the subjects included in the training brochure in the first phone call and recording any existing problems. In the fourth meeting, tele-nursing service will be provided through the "Telephone Counseling Protocol". EQ-5D-5L and OKS forms must be filled out again by patients at the routine check-up at the end of the fourth and sixth weeks after discharge.

experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having TDP surgery for the first time,
  • Having primary elective TKA surgery,
  • Having had a single (unilateral) knee prosthesis surgery,
  • Patients whose FFP indication is osteoarthritis,
  • No hearing, understanding, vision or speaking problems,
  • Agreeing to participate in the research voluntarily,
  • Able to understand and speak Turkish,
  • Least literate,
  • Those who have a mobile phone that can take photos of themselves or those nearby,
  • Patients who have a smartphone or a smartphone nearby,
  • Patients who do not develop serious complications that will delay discharge from the hospital

You may not qualify if:

  • Answering data collection forms incompletely
  • Being illiterate in Turkish
  • Patients who agreed to participate in the study but later left
  • Patients who cannot be reached when called and whose follow-up cannot be completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nevşehir Devlet Hastanesi

Nevşehir, Merkez, 50000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • HasanKU HasanKU, LECTURER

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GULSAH BEKTAS, LECTURER

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized: Participants are assigned to intervention groups by chance and control groups will be established. In the randomization method, whether the participants will be in the study group or the control group will be determined by the simple random numbers method using a computer program.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are two groups: control and study groups. Certain applications were planned to be applied to the control group and the study group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
LECTURER

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

November 13, 2023

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations