HypertensionNCT06816732
The Effect of Modular Education on Individuals Diagnosed With Hypertension
A study testing Nurse-led Modular Training in people with Hypertension, run by Ulviye Özcan Yüce at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nurse-led Modular Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypertension diagnosis duration is less than 6 months
- Having verbal communication problems
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Osmaniye Korkut Ata University
Osmaniye, 80000
About this study
Official title: The Effect of Nurse-led Modular Training on Self-efficacy and Disease Adaptation in Patients Diagnosed With Hypertension
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.
Read the 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
- Being tested
- Nurse-led Modular Training
- Keywords
- Hypertension, nursing, self-efficacy, modular training, adaptation to chronic illness
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Modular TrainingBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start30 Sep 2022
- Primary completion30 Oct 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pre-test post-test, randomized-controlled research method
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulviye Özcan Yüce
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulviye Özcan Yüce, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816732
- Sponsor's protocol ID
- E-59754796-050.99-65645
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keser E, Atik D, Ozcan Yuce U. Effect of Modular Training on Self-Management, Disease, and Treatment Adaptation in Individuals With Hypertension: A Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2026 Mar;28(3):e70238. doi: 10.1111/jch.70238.
PubMed 41863842
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-led Modular Training on Self-efficacy and Disease Adaptation in Patients Diagnosed With Hypertension
- ClinicalTrials.gov ID
- NCT06816732
- Acronym / sponsor ID
- E-59754796-050.99-65645
- Conditions
- Hypertension
- Keywords
- Hypertension, nursing, self-efficacy, modular training, adaptation to chronic illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ulviye Özcan YüceUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pre-test post-test, randomized-controlled research method
| Arm | Type | Receives |
|---|---|---|
| Modular training | Experimental | Behavioral: Nurse-led Modular TrainingThe 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- Hypertension diagnosis duration is less than 6 months
- Having verbal communication problems
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led Modular TrainingThe 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) | Behavioural | Modular training |
Primary outcome
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.
Effect of nurse-led modular education program on hypertensive individuals' adaptation to disease
Time frame: 3 months
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.
Effect of nurse-led modular education program on medication motivation of individuals diagnosed with hypertension
Time frame: 3 months
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.
Effect of a nurse-led modular education program on medication motivation of individuals diagnosed with hypertension
Time frame: 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 41863842Keser E, Atik D, Ozcan Yuce U. Effect of Modular Training on Self-Management, Disease, and Treatment Adaptation in Individuals With Hypertension: A Randomized Controlled Trial. J Clin Hypertens (Greenwich). 2026 Mar;28(3):e70238. doi: 10.1111/jch.70238.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led Modular Training in people with Hypertension, run by Ulviye Özcan Yüce at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of nurse-led modular training program on self-efficacy of individuals diagnosed with hypertension (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06816732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.