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Adherence to Infertility Treatment and Patient Centred Care Approach

Sponsor
Elif Balkan (Other)
Overall Status
Completed
CT.gov ID
NCT05078996
Collaborator
(none)
160
Enrollment
1
Location
6
Actual Duration (Months)
26.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the IVF Clinic of a university hospital between July - October 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment compliance. The data of the study were collected face to face through the "Introductory Information Form" "Patient Centered Care Form for Infertile Women" and "FertiQol Treatment Module".

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    160 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Patient Centred Care Approach in Adherence to Infertility Treatment
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Sep 20, 2020
    Actual Study Completion Date :
    Nov 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Adherence [from obtaining ethical permission to reaching sampling (approximately 6 months)]

      FertiQol Treatment Module was used to evaluate adherence to treatment. This module is a sub-module within FertiQol Scale which developed by Boivin et al. (2011). Module has 10 questions about treatments physical and emotional effects. Module has two subdimensions called "Environment" and "Tolerability" and each subdimensions and total scale score can between 0-100 points.

    Secondary Outcome Measures

    1. Patient Centred Care [from obtaining ethical permission to reaching sampling (approximately 6 months)]

      Patient Centred Care Questionnaire Form for Infertile Women was used to evaluate patient centred care approach. This questionnaire was prepared by researchers according to literature (IOM, 2001; Picker, 2001).There is no scoring for this tool.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosed with infertility

    • Has no commnunication problems

    Exclusion Criteria:

    • Communication problems (e.g language)

    • Diagnosed by diseases with reproductive problems but not infertility

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Elif Balkan İstanbul Turkey 34510

    Sponsors and Collaborators

    • Elif Balkan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elif Balkan, Master of Science, Istanbul University-Cerrahpasa
    ClinicalTrials.gov Identifier:
    NCT05078996
    Other Study ID Numbers:
    • Istanbul UC
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Elif Balkan, Master of Science, Istanbul University-Cerrahpasa
    patient centred care
    FertiQol
    infertility
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Oct 15, 2021