NCT06816732

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable hypertension

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

1 month

First QC Date

January 20, 2025

Last Update Submit

February 3, 2025

Conditions

Keywords

Hypertensionnursingself-efficacymodular trainingadaptation to chronic illness

Outcome Measures

Primary Outcomes (4)

  • Effect of nurse-led modular training program on self-efficacy of individuals diagnosed with hypertension

    It is expected that the pre-training self-efficacy scale score averages of the patients in the intervention group will increase after the training. For this purpose, the Hypertension Self-efficacy Scale was used. Self-Efficacy Scale in Hypertension was used to determine the self-efficacy levels of patients diagnosed with hypertension. The scale consists of 20 items. The items of the scale are in the 4-point Likert type, ranging from "not at all appropriate" (1 point) to "very appropriate" (4 points). The total score of the scale varies between 20-80 points. An increase in the total score obtained from the scale indicates an increase in the level of self-efficacy in hypertension.

    3 months

  • Effect of nurse-led modular education program on hypertensive individuals' adaptation to disease

    It is aimed that the average score of the patients in the intervention group on the chronic disease adaptation scale before the training will increase after the training.For this purpose, the chronic disease adjustment scale was used.The Scale of Adjustment in Chronic Diseases is a 5-point Likert type and consists of 25 items and three sub-dimensions: physical adjustment, social adjustment and psychological adjustment. The scale ranges from 1 (strongly disagree) to 5 (strongly agree). Negative items are reverse scored. The highest score is 125. An increase in the score obtained from the scale indicates a high level of patient adjustment to the disease.

    3 months

  • Effect of nurse-led modular education program on medication motivation of individuals diagnosed with hypertension

    The Turkish Modified Morisky Scale was used to test this. The Turkish Modified Morisky Scale is a reliable, easy-to-apply scale consisting of six questions that can separately evaluate the knowledge and motivation levels regarding drug use habits. In the evaluation of the answers given as "Yes" or "No"; the yes answer to the 2nd and 5th questions was calculated as 1 point, the no answer as 0 points; and the yes answer to the other questions was calculated as 0 points, the no answer as 1 point. The total score received by the patient from the 1st, 2nd and 6th questions; 0 or 1 indicates a low motivation level, while values above 1 indicate a high motivation level. The total score received from the 3rd, 4th and 5th questions; 0 or 1 indicates a low knowledge level, and values above 1 indicate a high knowledge level.

    3 months

  • Effect of a nurse-led modular education program on medication motivation of individuals diagnosed with hypertension

    Turkish Modified Morisky Scale (Moriskiy motivation level) was used to evaluate the effect of the nurse-led modular training program on medication motivation of individuals diagnosed with hypertension.This scale questions the belief in the benefit of the treatment, the habit of taking the medications on time, and the situation of forgetting or stopping to take the medication. In the evaluation of the answers given as "Yes" or "No"; the yes answer to the 2nd and 5th questions was calculated as 1 point, the no answer as 0 points; and the yes answer to the other questions was calculated as 0 points, the no answer as 1 point. The total score received by the patient from the 1st, 2nd and 6th questions; 0 or 1 indicates a low motivation level, while values above 1 indicate a high motivation level. The total score received from the 3rd, 4th and 5th questions; 0 or 1 indicates a low knowledge level, and values above 1 indicate a high knowledge level.

    3 months

Study Arms (2)

Modular training

EXPERIMENTAL

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.

Behavioral: Nurse-led Modular Training

Control

NO INTERVENTION

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.

Interventions

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)

Modular training

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding was impossible because the research involved a training program.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A pre-test post-test, randomized-controlled research method
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2025

First Posted

February 10, 2025

Study Start

September 30, 2022

Primary Completion

October 30, 2022

Study Completion

February 28, 2023

Last Updated

February 10, 2025

Record last verified: 2025-02

Locations