NCT04831463

Brief Summary

Aims The study aims to examine the effect of "IHAPIM" program on health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies of immigrant men. Design This study is a two centre, double-blind, randomized controlled trial. Methods We attempt to report this randomized controlled trial to comply with the SPIRIT. The study population consist of 95 immigrant men live at north of Turkey. The study, between March 2020-March 2021 were held in the two district predominantly immigrants. The participants were randomly divided into experimental and control group. The experimental (N = 49) received a short-term IHAPIM program (5 week, 1 hr per week, 10 hr in total). Measurements were obtained during pre- and post-test from experimental and control group (N = 46). In this study, participants and statistician who conducted the research blinded. Discussion The efficacy of health promotion interventions are known. However, the health promotion interventions for immigrants men performed by public health nurse are not available. At the same time, the effect of health promotion interventions for immigrants men are unknown. Impact This study is expected to provide a piece of credible evidence of the the health promotion interventions for immigrants men performed by public health nurse and efficacy of health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies in immigrant men group. It is assumed that health promotion interventions specific to male health and sensitive to the language of immigrants lead to a beneficial results on health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies in immigrant men. If "IHAPIM" program perform in practice by public heath nurse. It can be effectively improve immigrant men's health variables such as health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

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

March 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 1, 2021

Last Update Submit

April 26, 2021

Conditions

Keywords

Immigrant Health, Men's Health, Health Promotion

Outcome Measures

Primary Outcomes (1)

  • Increasing health perception and responsibility of immigrant men

    After health promotion intervention (IHAPIM) this outcome will obtained

    3 month

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental (N = 49) received a short-term IHAPIM program by one-on-one interview (5 week, 1 hr per week, 10 hr in total).

Behavioral: Increasising Health Awareness Program for Immigrant Men

control group

NO INTERVENTION

Firstly, Pre-tests were applied to the men in the control group. No intervention was applied to this group. Post-tests were made 3 months after finished intervention which applied to experimental group.

Interventions

The IHAPIM program is a health promotion intervention. The aim of intervention improve health perception and responsibilitiy

experimental group

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe utiling of healthcare services by immigrant men is lower than immigrant women. Only men were recruited.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study
  • Be between the ages of 18 and 50
  • Being a male
  • No communication barriers
  • Being a immigrant
  • To be able to read and write Arabic language

You may not qualify if:

  • Being younger than 18 or over 50
  • Be woman
  • Inability to communicate with any problem such as hearing problem, speech impediment
  • Living undocumented
  • Refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Acceptance of Health CareMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • İlknur Aydin AVCI, Prof.

    Ondokuz Mayıs University

    STUDY DIRECTOR
  • Metin Yılmaz, Prof.

    Ondokuz Mayıs University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Nursing Department

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

March 15, 2020

Primary Completion

November 20, 2020

Study Completion

March 15, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations