The Effect of Modular Education on Individuals Diagnosed With Hypertension

NCT ID: NCT06816732

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-02-28

Brief Summary

Aim:This study focused on patients with hypertension to investigate the effect of a nurse-led counseling program on their self-efficacy and disease adherence.

Detailed Description

This study adopted a randomized-controlled and intervention research method. Data were collected between September 2022 and February 2023 at the internal medicine outpatient clinic of Adana City Hospital.

Participants were recruited using random sampling. Simple randomization was used to allocate both groups equally and randomly (https://www.randomizer.org/). The researcher first created a randomization list. Then, she assigned participants to the intervention and control groups according to the list. Blinding was impossible because the research involved a training program. A power analysis (G*Power 3.1.9.4) was performed based on the effect size (d = 0.93) reported by Zhang et al. (Zhang et al., 2021). The results showed that a sample of 62 would be large enough to detect significant between-group differences (power 95%, margin of error 5%, and confidence interval 95%). The results showed that a sample of 42 was large enough to detect significant differences [alpha= 0.05 and power (1- beta) 0.80]. However, each group comprised 23 participants to avoid missing data and the execute parametric tests.Data were collected using a personal information form, the Hypertension Self-Efficacy Scale (HSES), the Modified Morisky Scale (MMS), and the Adaptation to Chronic Illness Scale (ACIS). The inclusion criteria were (1) having had hypertension at least for six months, (2) being an adult (over 18), (3) not having received training on hypertension before, (4) having no communication problems, (5) not being pregnant, and (6) volunteering.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Modular training

The intervention group participants filled out all the data collection tools in the first interview and three months later. They received modular training by phone 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the first interview.

Group Type: EXPERIMENTAL

Nurse-led Modular Training

Intervention Type: BEHAVIORAL

The intervention group participants filled out all the data collection tools in the first interview and three months later. They received modular training by phone 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the first interview.The modular training addressed (1) defining hypertension, (2) systemic effects of hypertension, (3) general effects of antihypertension drugs, (4) regular medication and blood pressure monitoring, and (5) eating a healthy diet and being active (what to do for a better heart health and a more stable blood pressure)

Control

The control group participants filled out all the data collection tools in the first interview and three months later. They did not receive any modular training.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-led Modular Training

The intervention group participants filled out all the data collection tools in the first interview and three months later. They received modular training by phone 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the first interview.The modular training addressed (1) defining hypertension, (2) systemic effects of hypertension, (3) general effects of antihypertension drugs, (4) regular medication and blood pressure monitoring, and (5) eating a healthy diet and being active (what to do for a better heart health and a more stable blood pressure)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Having had hypertension at least for six months
• Being an adult (over 18),
• Not having received training on hypertension before,
• Having no communication problems,
• Not being pregnant,
• Volunteering

Exclusion Criteria

• Hypertension diagnosis duration is less than 6 months
• Having verbal communication problems
• Not volunteering to participate in the study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulviye Özcan Yüce

OTHER

Sponsor Role: lead

Responsible Party

Ulviye Özcan Yüce

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Osmaniye Korkut Ata University

Osmaniye, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-59754796-050.99-65645

Identifier Type: -

Identifier Source: org_study_id