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CompletedNCT05316454Updated Apr 7, 2022

Self-Efficacy Support on Medication Adherence and Self-Efficacy Levels in Hypertension Patients

An interventional study of self-efficacy support in Hypertension, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 50 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
50 Years to 72 Years
Sex
All
01

Study summary

Background:Health professionals are responsible for the education of hypertension patients.

Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.

Methods: This research is randomized controlled interventional research. The research is conducted inTurkey June-December2021.The research sample included 63hypertension patients who met the research's research requirements.According to the sequence of the arrival at the hospital, data were separated into groups with odd(intervention group)and double(control group)numbers.The necessary forms for both groups' pre-test data were filled out face-to-face. The intervention group received hands-on blood pressure measurement training with the "Hypertension Training Manual",including how to self-measure blood pressure.Over the course of the research, patients were asked to check their blood pressure twice a day at home and record the results.The patients in the intervention group were reminded of their blood pressure measurement three times a week by SMStechnique for three months to avoid forgetting it.Three months later, the same forms for the post-test data of both groups were filled out with an online survey method.The data were evaluated using the single-blind study.

Read the detailed description

Background:Health professionals are responsible for the education of hypertension patients.

Aim:The aim of this research is to see how self-efficacy support affects hypertension patients' medication adherence and self-efficacy levels.

The Research's Population and Sample Hypertension patients who applied to the cardiology outpatient clinics at a Hospital in Turkey between June and December 2021 formed the target population of the research. The research sample included 63 hypertension patients over the age of 18 who met the research requirements and agreed to participate.

A priori power analysis was used to determine the sample size, and it was determined that each of the intervention and control groups needed at least 30 hypertension patients for the research's power to exceed 80% at the 95% confidence interval, 0.05 significance level, and medium effect size. Given the possibility of data loss owing to a variety of factors, it was decided to include 100 hypertension patients in the research sample. Because 12 patients wished to withdraw from the research and 25 patients did not complete the final applications, the research sample consisted of 63 hypertension patients, 31 in the intervention group and 32 in the control group.

Criteria for Research Inclusion All intervention and control groups were required to meet the inclusion criteria below.

  • With a diagnosis of essential hypertension, follow up for at least 6 months,
  • Using antihypertensive drugs,
  • Not changing the antihypertensive medication in the last 1 month,
  • Not having mental or communication problems,
  • Being the age of 18 or older,
  • Having at least primary education level,
  • Not being a pregnant or nursing mother. Data Collection Data Collection Tools To Be Used in the Research The research data were collected using the "Patient Descriptive Information Form", "Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy-Efficacy Scale in Hypertensive Patients." Patient Introductory Information Form This form, which has been developed by the researchers based on the literature and has 19 questions, includes the socio-demographic characteristics of the patients and their disease-related features.

Self-Efficacy - Efficacy Scale The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.

Medication Adherence Self-Efficacy Scale in Hypertensive Patients The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.

Used Materials for Self-Efficacy Support Hypertension Education Booklet The Hypertension Education Booklet, which was created by the researchers based on the literature review, contains information about the disease and its treatment, treatment methods, lifestyle changes that are effective in the management of hypertension, the importance of treatment compliance, and blood pressure measurement at home.

For the booklet, 1 internal medicine specialist, 3 nurse faculty members, and 1 specialist nurse provided expert opinions. In addition, three hypertension patients were given the booklet to assess its comprehension, and arrangements were made based on their ideas. The survey was completed after Item and Content validity analyses were performed.

Blood Pressure Monitor Given the uncertainty of measurement by auscultation, the Hypertension Guidelines in the 2015 Canadian Education Program advocate using an automatic sphygmomanometer for office blood pressure measurement.Blood pressure is now measured at home using an upper arm blood pressure monitor. As a result, an appropriate blood pressure monitor, which enables self-measured blood pressure monitoring at home, with the BAP project number TSA-2021-8985 was delivered within the scope of the project. The device complies with the European Norm EN 60601-1-2.

Phone "Don't forget to measure your blood pressure in the morning and evening!" message sent 3 times a week by SMS method to the patients in the intervention group. In addition, the patients were contacted by phone at the end of the first, second, and third months to acquire information regarding the research process.

Research Implementation The objective of the research and the manner of application was explained to all patients in the intervention and control groups who met the eligibility requirements. Patients who agreed to take part in the research were required to complete an "Informed Consent Form for Volunteers." As a pre-test, both groups were given the "Patient Introductory Information Form","Self-Efficacy-Efficacy Scale", and "Medication Adherence Self-Efficacy Scale in Hypertensive Patients" through a face-to-face interview.

Separation of Groups Patients were sorted into odd and even numbers according to the order in which they arrived at the hospital in the research, regardless of their age or gender, as long as the number of participants in the intervention and control groups was equal. The method was repeated until a total of 100 data points were collected, with odd numbers representing the intervention group and even numbers representing the control group.

Intervention Group Patient education and blood pressure measurement training took place in the ECG room of the outpatient clinic which is equipped to instruct patients. The "Hypertension Education Booklet" was used to instruct the patients. Following that, the patient received blood pressure measurement training, including a demonstration of how to self-measure blood pressure. The patient was instructed to repeat the same process. The researcher provided retraining in the event of errors or shortcomings. The training continued until the patient performed the accurate measurement. It took around half an hour. The patients were given a blood pressure monitor to use at home to test their blood pressure. Patients were asked to take their blood pressure at home twice a day and record the results during the research. Patients in the intervention group were texted three times a week for three months to remind them to take their blood pressure.

The patients were called by phone after the first month to control the procedure and acquire information about the research process. In addition, the patients' queries were answered and information on the various events that occurred was acquired. Similarly, patients were also reached by phone after the second month to control the process and acquire information about the research process. The same forms were given to the patients in the intervention group as a post-test at the end of the third month, utilizing an online survey method.

Control Group The control group received no intervention after the pre-test data of the control group were gathered face to face. The same forms were collected as post-test data via an online survey method at the end of the third month.

Pre-Application The researcher invited two patients who applied to the outpatient clinic to read and answer the survey questions before the research to assess the intelligibility of the questions in the data collection form. All of the questions were found to be clear and of adequate scope. The data of the patients, taken to the pre-application, were not included in the research data.

Data Evaluation The statistics were evaluated using the single-blind study. The data were analyzed in the SPSS 20 Package Program. To establish their distribution among the groups, frequency and percentage distributions were utilized. The intervention and control groups were compared using the chi-square test. To compare two independent groups, an "independent sample t-test" was utilized. To compare two dependent groups, a "Paired t-test" was performed. Descriptive statistics (mean and standard deviation) were used. The statistical significance cut-off value was set at 0.05.

02

Conditions studied

  • Hypertension

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Keywords

  • Nursing, hypertension, self-efficacy, self-efficacy support
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 63 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Ataturk University is the lead sponsor of 456 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 72 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All intervention and control groups were required to meet the inclusion criteria below.

  • With a diagnosis of essential hypertension, follow up for at least 6 months,
  • Using antihypertensive drugs,
  • Not changing the antihypertensive medication in the last 1 month,
  • Not having mental or communication problems,
  • Being the age of 18 or older,
  • Having at least primary education level,
  • Not being a pregnant or nursing mother.

Exclusion criteria

Exclusion Criteria:

All intervention and control groups were required to meet the inclusion criteria below.

  • With a diagnosis of essential hypertension, follow up for at least 6 months,
  • Using antihypertensive drugs,
  • Not changing the antihypertensive medication in the last 1 month,
  • Not having mental or communication problems,
  • Being the age of 18 or older,
  • Having at least primary education level,
  • Not being a pregnant or nursing mother.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Experimental

    Patients with hypertension benefit from self-efficacy support in terms of medication adherence and self-efficacy.

    Behavioral: self-efficacy support

  • No intervention
    Control

    No change.

Interventions

  • Behavioralself-efficacy support

    self-efficacy support

06

What researchers measure

Primary outcomes

  1. Self-Efficacy - Efficacy Scale

    The scale evaluates generic self-efficacy-efficacy perception and does not belong to any subjective category. The Self-Efficacy-Efficacy Scale is a 23-item, 5-point Likert-type scale with a minimum of 23 points and a maximum of 115 points.

    Time frame: 3months

  2. Medication Adherence Self-Efficacy Scale in Hypertensive Patients

    The scale consists of 13 items and is in a four-point Likert type. The scale can be used to determine the lowest 13 and highest 52 points. The increase in the scale score shows that the individuals' compliance with the antihypertensive medication is above average.

    Time frame: 3months

07

Study locations

1 site
  • Atatürk University Faculty of Nursing
    Erzurum, Center 25242, Turkey (Türkiye)
08

References and documents

Publications

  • Erden Y, Yildiz GN, Ciftci B, Avsar G, Ozek S, Ozbek E, Sarialioglu A. The effect of self-management program with tele-nursing based on the Roper-Logan-Tierney model on self-care of hypertensive patients: a randomized controlled trial. BMC Nurs. 2025 Mar 25;24(1):313. doi: 10.1186/s12912-025-02854-y. PubMed 40133854 ↗

Individual participant data

Plan to share: No — The article is intented to be shared after it is published.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2021 to primary completion in Sep 2021, 3 months.

Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 3 months is below that.

Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2022
First posted
Apr 7, 2022
StartActual
Jun 1, 2021
Primary completionActual
Sep 1, 2021
CompletionActual
Feb 1, 2022
Last update
Apr 7, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05316454
Lead sponsor
Ataturk University
Responsible party
Bahar Ciftci (Principal Investigator, Ataturk University) — Principal investigator
First posted
Apr 7, 2022
Start date
Jun 1, 2021
Primary completion
Sep 1, 2021
Completion
Feb 1, 2022
Last update
Apr 7, 2022

Study contacts

BAHAR Çiftçi, phd
study director · Ataturk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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