NCT06784596

Brief Summary

Following total knee arthroplasty, patients may encounter numerous problems that can hinder the performance of daily living activities, negatively impact quality of life, and increase morbidity and mortality rates. In this context, this study was designed to evaluate the effect of nursing education and tele-consultation, based on Watson's Theory of Human Caring, on daily living activities, self-care agency, and quality of life in patients undergoing total knee arthroplasty.

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
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 15, 2025

Last Update Submit

January 17, 2025

Conditions

Knee Arthroplasty, Total

Keywords

total knee replacementeducationteleconsultingactivities of daily livingself-care abilityquality of life

Outcome Measures

Primary Outcomes (10)

  • KATZ Activities of Daily Living Scale

    The scale was developed in 1963 by Katz and his colleagues to assess individuals' basic activities of daily living. This scale measures the level of dependency in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6, with lower scores indicating a higher level of dependence. The scale classifies as follows: 0-2 points indicates dependent, 3-4 points indicates partially dependent, and 5-6 points indicates independent.

    1 day

  • KATZ Activities of Daily Living Scale

    The scale was developed in 1963 by Katz and his colleagues to assess individuals' basic activities of daily living. This scale measures the level of dependency in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6, with lower scores indicating a higher level of dependence. The scale classifies as follows: 0-2 points indicates dependent, 3-4 points indicates partially dependent, and 5-6 points indicates independent.

    2 day

  • KATZ Activities of Daily Living Scale

    The scale was developed in 1963 by Katz and his colleagues to assess individuals' basic activities of daily living. This scale measures the level of dependency in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6, with lower scores indicating a higher level of dependence. The scale classifies as follows: 0-2 points indicates dependent, 3-4 points indicates partially dependent, and 5-6 points indicates independent.

    3 weeks

  • KATZ Activities of Daily Living Scale

    The scale was developed in 1963 by Katz and his colleagues to assess individuals' basic activities of daily living. This scale measures the level of dependency in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6, with lower scores indicating a higher level of dependence. The scale classifies as follows: 0-2 points indicates dependent, 3-4 points indicates partially dependent, and 5-6 points indicates independent.

    6 weeks

  • KATZ Activities of Daily Living Scale

    The scale was developed in 1963 by Katz and his colleagues to assess individuals' basic activities of daily living. This scale measures the level of dependency in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. The total score ranges from 0 to 6, with lower scores indicating a higher level of dependence. The scale classifies as follows: 0-2 points indicates dependent, 3-4 points indicates partially dependent, and 5-6 points indicates independent.

    12 weeks

  • Lawton Brody Activities of Daily Living Scale

    The scale was developed in 1969 by Lawton and Brody to assess individuals' instrumental activities of daily living. This scale includes a total of eight items: using the telephone, shopping, preparing meals, housekeeping, doing laundry, traveling, managing medications, and handling finances. The total score ranges from 0 to 8, with lower scores indicating a higher level of dependence.

    1 day

  • Lawton Brody Activities of Daily Living Scale

    The scale was developed in 1969 by Lawton and Brody to assess individuals' instrumental activities of daily living. This scale includes a total of eight items: using the telephone, shopping, preparing meals, housekeeping, doing laundry, traveling, managing medications, and handling finances. The total score ranges from 0 to 8, with lower scores indicating a higher level of dependence.

    2 day

  • Lawton Brody Activities of Daily Living Scale

    The scale was developed in 1969 by Lawton and Brody to assess individuals' instrumental activities of daily living. This scale includes a total of eight items: using the telephone, shopping, preparing meals, housekeeping, doing laundry, traveling, managing medications, and handling finances. The total score ranges from 0 to 8, with lower scores indicating a higher level of dependence.

    3 weeks

  • Lawton Brody Activities of Daily Living Scale

    The scale was developed in 1969 by Lawton and Brody to assess individuals' instrumental activities of daily living. This scale includes a total of eight items: using the telephone, shopping, preparing meals, housekeeping, doing laundry, traveling, managing medications, and handling finances. The total score ranges from 0 to 8, with lower scores indicating a higher level of dependence.

    6 weeks

  • Lawton Brody Activities of Daily Living Scale

    The scale was developed in 1969 by Lawton and Brody to assess individuals' instrumental activities of daily living. This scale includes a total of eight items: using the telephone, shopping, preparing meals, housekeeping, doing laundry, traveling, managing medications, and handling finances. The total score ranges from 0 to 8, with lower scores indicating a higher level of dependence.

    12 weeks

Secondary Outcomes (10)

  • Short Form 36 Quality of Life Scale

    1 day

  • Short Form 36 Quality of Life Scale

    2 day

  • Short Form 36 Quality of Life Scale

    3 weeks

  • Short Form 36 Quality of Life Scale

    6 weeks

  • Short Form 36 Quality of Life Scale

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Group provided with teleconsulting supported training

EXPERIMENTAL

This group will be the group that will receive training and teleconsultancy services.

Other: Teleconsulting supported training

Group provided with standard care

NO INTERVENTION

This group will only be monitored with standard care and will not receive education or telecounseling.

Interventions

Teleconsulting supported trainingOTHER

Patients in this group will be provided with training the day before surgery, on the morning of surgery and on the day of discharge, and will receive teleconsulting services at the 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th and 12th weeks after discharge. will be given.

Group provided with teleconsulting supported training

Eligibility Criteria

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

You may qualify if:

  • Individuals who voluntarily consent to participate,
  • Aged 18 years or older,
  • Those scheduled for their first Total Knee Arthroplasty (TKA),
  • Patients undergoing unilateral knee prosthesis surgery,
  • Patients without verbal communication barriers for face-to-face and telephone interactions,
  • Patients who own a smartphone and have the WhatsApp application installed.

You may not qualify if:

  • Patients undergoing Total Knee Arthroplasty (TKA) as an emergency surgical intervention,
  • Patients diagnosed with any psychiatric disorder,
  • Patients who wish to withdraw from the study voluntarily,
  • Patients whose communication is interrupted before the completion of the data collection phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (2)

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND

  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

    PMID: 14044222BACKGROUND

Study Officials

  • Turgut Şöhret, PhD student

    Turgut ŞÖHRET

    STUDY CHAIR

Central Study Contacts

Dilek Gürçayır, asst. prof. dr.

CONTACT

+905387406793dilekgurcayir@gmail.com

Turgut Şöhret, PhD student

CONTACT

+905523052870turgutsohret@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were not told which group they were in. In this way, single blinding was achieved.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A design with two groups, one experimental and one control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)