NCT04916717

Brief Summary

This study aims to determine the effect of counseling on quality of life and self-care agency for patients who are scheduled for TKR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

May 27, 2021

Last Update Submit

June 4, 2021

Conditions

Keywords

total knee replacementnursing counselingcounselingquality of lifeself care agency

Outcome Measures

Primary Outcomes (2)

  • Quality of life (SF-36)

    in quality of life change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period)

    up to 16 weeks

  • Self Care Agency

    in self care agency change from the preoperative period to 6-8th weeks and 14-16th weeks (postoerative period)

    up to16 weeks

Study Arms (1)

Counseling

OTHER

Quasi-experimental design. Face-to-face and telephone counseling were applied to individuals in the intervention group.

Other: Counseling

Interventions

Face-to-face and telephone counseling were applied to individuals in the intervention group.

Also known as: Patient education
Counseling

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing TKA for the first time, being scheduled to have unilateral TKA, having surgery for osteoarthritis, having no postoperative complications, fulfilment of discharge criteria after surgery, being aged 18 years or older, being conscious, orientation to place and time, having no hearing or speech problems, ability to understand and speak Turkish, being at least literate, not being diagnosed with any psychiatric diseases and not having a history of cancer.

You may not qualify if:

  • diagnoses of neurological (e.g. Alzheimer's disease) and psychiatric disorders (e.g. schizophrenia) likely to affect cognitive functions, first accepting to participate in the study and then dropping out of the study, development of complications during follow-up (e.g. infection), unavailability when called and lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak University Education and Research Hospital

Uşak, Merkez, 64000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

CounselingPatient Education as Topic

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth EducationPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: This is a quantitative study and has a quasi-experimental design with a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 7, 2021

Study Start

April 1, 2018

Primary Completion

July 1, 2018

Study Completion

December 31, 2019

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations