NCT04970420

Brief Summary

Purpose: The aims of the research are to determine the effects of individual trainings on family planning given to migrant women (Ahıska Turks), repetitive trainings via mobile applications, telephone counseling initiatives on women's health responsibility levels, family planning knowledge and attitudes. Design: This pretest-posttest is an interventional quasi-experimental research. Method: Standard protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement 2013 checklist is used in this study. The CONSORT (Consolidated Standards of Reporting Trials) flowchart is used in this protocol. This study will be carried out with immigrant (Ahıska Turks) women between the ages of 15-49 who are registered in Üzümlü Family Health Center in Üzümlü district of Erzincan province. In this study, individual training on family planning and health responsibility, repetitive training via mobile application and telephone counseling initiatives will be made. The same applications will be applied to the control group after the study data is collected. Hypotheses: H1: Mobile applications for family planning, telephone counseling and individual training have an impact on the family planning attitudes of immigrant women. H1: Mobile applications for family planning, telephone counseling and individual trainings have an impact on the family planning knowledge level of immigrant women. H1: Mobile applications, telephone counseling and individual trainings for health responsibility have an impact on the level of health responsibility of migrant women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Status
unknown

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

June 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

June 30, 2021

Last Update Submit

July 11, 2021

Conditions

Keywords

Family planningKnowledgeEmigrationAttitudeImmigration

Outcome Measures

Primary Outcomes (3)

  • Healthy Lifestyle Behaviors Scale II-Health Responsibility Sub-Dimension

    The lowest score in the Health Responsibility Sub-Dimension was determined as 9 and the highest as 36 points. As the score obtained from the Sub-Dimension of the Scale increases, the health responsibility increases. Health Responsibility sub-dimension Cronbach Alpha coefficient is 0.77.

    Change in health responsibility at baseline and after 12 weeks.

  • Family Planning Attitude Scale

    A minimum of 34 and a maximum of 170 points can be obtained from the scale. The scale has 3 sub-dimensions: "Attitude of the Society towards Family Planning", "Attitude towards Family Planning Methods" and "Attitude towards Birth". Evaluation of the scale is done as individuals with higher scores have more positive family planning attitudes. The internal consistency and homogeneity coefficients determined by the alpha correlations of the scale were found to be 0.90 in total.

    Change in health responsibility at baseline and after 12 weeks.

  • Family Planning Information Form

    This form, which was developed by the researcher based on the literature, consists of questions that include mobile application and telephone counseling comprehensive initiatives. A minimum of 0 and a maximum of 75 points are taken from the form. Evaluation of the form is made as individuals with high scores have knowledge about family planning.

    Change in health responsibility at baseline and after 12 weeks.

Secondary Outcomes (1)

  • Family Planning Program Evaluation Form

    Level of satisfaction with the programs implemented after 12 weeks

Study Arms (2)

HeRFAPIW

EXPERIMENTAL

Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).

Other: Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).

Control group

ACTIVE COMPARATOR
Other: Control group

Interventions

In this study, individual training, training via mobile application and telephone counseling will be given to the experimental group. During the meetings, attention will be paid to the pandemic rules.

HeRFAPIW

Individual training, mobile application and telephone counseling will be given to the control group after the study data is collected.

Control group

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • To be registered at the family health center
  • Being literate
  • Ability to communicate verbally
  • Volunteering to participate in the research
  • Owning a smartphone or a phone belonging to any member of the family that can also be used by the participant
  • Having internet access at home or at work
  • Internet use
  • Able to speak and write Turkish
  • Being a migrant woman in the age group of 15-49

You may not qualify if:

  • Having a physical or mental health problem
  • Menopausal, tubal ligation or spouse vasectomy
  • Inability to reach by phone/visit
  • Relocation of women to another place
  • Illness and death of the sampled woman
  • To have received training on effective family planning

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Behavior

Interventions

Family Planning ServicesControl Groups

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health ServicesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ezgi DEMİRTÜRK SELÇUK, MSc

CONTACT

Birsel Canan DEMİRBAĞ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician

Study Record Dates

First Submitted

June 30, 2021

First Posted

July 21, 2021

Study Start

July 1, 2021

Primary Completion

October 1, 2021

Study Completion

May 1, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share