- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06816732
The Effect of Modular Education on Individuals Diagnosed With Hypertension
The Effect of Nurse-led Modular Training on Self-efficacy and Disease Adaptation in Patients Diagnosed With Hypertension
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Osmaniye, Turkey, 80000
- Osmaniye Korkut Ata University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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)
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of nurse-led modular training program on self-efficacy of individuals diagnosed with hypertension
Time Frame: 3 months
|
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.
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3 months
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Effect of nurse-led modular education program on hypertensive individuals' adaptation to disease
Time Frame: 3 months
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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.
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3 months
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Effect of nurse-led modular education program on medication motivation of individuals diagnosed with hypertension
Time Frame: 3 months
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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.
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3 months
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Effect of a nurse-led modular education program on medication motivation of individuals diagnosed with hypertension
Time Frame: 3 months
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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.
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-59754796-050.99-65645
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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