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HypertensionNCT05343663

Tele-Nursıng Based On Roper-Logan-Tıerney Model On Self-Care Of Hypertensıon Patıents: A Randomızed Controlled Trıal

A study testing Education in people with Hypertension, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research; The aim of this study is to examine the effects of self-management support given by tele-nursing for hypertension patients on patients' adherence to treatment and disease, self-efficacy level, self-care management and satisfaction level. Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Hypertension
What is being tested?
Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2022to 1 Dec 2022
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 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Follow-up for at least 6 months with the diagnosis of essential hypertension,
  • Using antihypertensive drugs,
  • No change in antihypertensive drug treatment in the last 1 month,
  • Not having any other accompanying chronic disease (Diabetes mellitus, cancer, chronic kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
  • Having no mental or communication problems,
  • Computer/tablet/smartphone etc. to watch videos. having technological tools,
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  • Having internet,
  • Being over 40 years old,
  • Having at least primary education level,
  • Not being pregnant or lactating,

Who cannot join

  • Follow-up for less than 6 months with the diagnosis of essential hypertension,
  • Not using antihypertensive drugs,
  • Changes in antihypertensive drug therapy in the last 1 month,
  • Presence of another concomitant chronic disease (Diabetes mellitus, cancer, chronic kidney failure, chronic obstructive pulmonary disease, heart failure, etc.),
  • Having a mental or communication problem,
  • Computer/tablet/smartphone etc. to watch videos. lack of technological tools,
Show all 10Show fewer
  • Lack of internet,
  • Being under the age of 18,
  • Being illiterate
  • Being pregnant or breastfeeding,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Atatürk University Faculty of Nursing

    Erzurum, 25000

Other trials in Turkey (Türkiye)

About this study

Official title: Effect Of Self-Management Program Wıth Tele-Nursıng Based On Roper-Logan-Tıerney Model On Self-Care Of Hypertensıon Patıents: A Randomızed Controlled Trıal

The purpose of this research; The aim of this study is to examine the effects of self-management support given by tele-nursing for hypertension patients on patients' adherence to treatment and disease, self-efficacy level, self-care management and satisfaction level. This research is a randomized controlled and pretest-posttest applied design. The research will be carried out in Van Yüzüncü Yıl University Research Hospital with patients previously diagnosed with hypertension. The population of the research will consist of patients who have previously applied to the hospital where the research will be conducted and who have been diagnosed with hypertension who meet the research criteria. After the power analysis, it is planned to include total 60 hypertension patients in the sample of the study. All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application, and their consent will be obtained. The pretest forms required for the research will be filled in by face-to-face interview method for all patients. In the study, the number of individuals in the randomization group will be determined by using the computer program, provided that they are equal in number. All materials prepared for self-management support will be delivered to the patients in the intervention group and they will be taught how to use them by the demonstration method. Patients will be asked to do the same procedure and the process will continue until they ensure correct use. Participants will be informed that there is a phone number that they can call whenever they want, when there are subjects that are not understood or that need to be repeated. Patients will be called three times a week and necessary checks will be made on blood pressure monitoring, nutrition, weight control, etc. In this way, patients in the intervention group will be followed remotely by tele-nursing for 3 months, their questions will be answered when they encounter problems, and guidance will be given in case of emergency. No intervention will be made in the control group. Necessary forms will be re-administered to all patients in both groups after 3 months as a post-test. At the end of the research, a comparison of the intervention and control groups will be made.

Read the detailed description

Type of research This project is a randomized controlled and pretest-posttest applied design. Location and Characteristics of the Research The research will be carried out in Van SBU Training and Research Hospital Research Hospital with patients who have been diagnosed with hypertension before.

The number of cardiology outpatient clinics of Van Training and Research Hospital is 5. In our hospital, there are cardiology and internal departments that also include hypertension patients. There are 70 patients per day per cardiology outpatient clinic. The majority of them are individuals with hypertension and hypertension, as well as additional chronic diseases. It is questioned whether individuals follow their weight, whether they change their eating and drinking habits, whether they use their medications regularly, and finally whether they follow their blood pressure regularly. After this questioning, examination and various tests (blood analysis, ultrasound, etc.), the medicines of the patients are regulated. In general, patients are called for control every 2 months. However, this period is extended for individuals who take the warnings into account, measure their blood pressure regularly and see that it is stable at the expected level.

Research Population and Sample Selection The population of the research will consist of patients who have previously applied to the hospital where the research will be conducted and who have been diagnosed with hypertension who meet the research criteria.

The sample was calculated using the Hill-Bone Hypertension Treatment Adherence Scale, which was used in 2 studies. In order to determine the sample size, a priori power analysis was performed and it was determined that at least 28 hypertension patients were required for each of the intervention and control groups in order for the power of the study to exceed 80% at the 95% confidence interval, 0.05 significance level and medium effect size. In case of data loss, a total of 60 (total) data will be collected by including 10% backup sample to this number. After the posttest data are collected, the power analysis will be looked at again. In the final power analysis, this rate is expected to exceed 90%.

Data Collection All patients in the intervention and control groups who meet the inclusion criteria will be verbally informed about the purpose of the study and the method of application. "Informed Consent Form" will be filled in for the patients who agree to participate in the study. Then, the pre-test forms will be filled in by face-to-face interview method for all patients in the intervention and control groups.

In the study, "stratification and block randomization methods" will be used in assigning participants to control and intervention groups. In the literature, it has been reported that age, gender and educational status are among the factors affecting drug and disease compliance, self-efficacy and self-management of hypertension patients. In line with this information, "age, gender and educational status" variables will be used in the stratification of hypertension patients in the study.

Enterprise Group; All materials prepared for Self-Management Support will be delivered to the patients and they will be taught how to use them by the demonstration method. Patients will be asked to do the same procedure and will continue to be taught until they use it correctly. Participants will be informed that there is a phone number that they can call whenever they want, when there are subjects that are not understood or that need to be repeated.

Phone; All patients will be registered on the telephone line to be used by the researchers and the telephone will be used only for research. The phone will be available at the cardiology nurse Sümeyra Autonomous. When the cardiology nurse Sümeyra Özerk could not be reached, so that the patients are not victims and that they can reach the phone whenever they want, the project coordinator Dr. Instructor A phone call will be made to member Bahar Çiftçi. At the same time, a group with the entire project team will be established and the arrangements for the project will be discussed there.

Management of hypertension, ability to measure blood pressure at home, edema control, nutrition, movement, salt restriction, etc. Self-management support will be provided by providing training to teach. Patients will be called three times a week and necessary controls will be provided on training, blood pressure monitoring, nutrition, weight control, etc. It will be required to measure and record blood pressure twice a day with a digital and easy-to-use sphygmomanometer. In addition, it will be reminded that height-weight, blood pressure should be measured and recorded. It will be ensured that the materials sent to the patients are used in the measurement of height, weight and blood pressure. Patients will be reminded that they need to take measurements twice a day, and they will be warned to call the phone number that they can reach in case of emergency if an abnormal situation is encountered. In this way, patients in the intervention group will be followed remotely by tele-nursing for 3 months, their questions will be answered when they encounter problems, and guidance will be given in case of emergency.

The content of the videos will be the same as the Training Booklet. The videos are planned to be between 3-5 minutes. It is planned to have videos that are explained in simple language that patients can understand. In addition, the videos will be presented to the patient after review. In the inclusion criteria of the research, "Computer/tablet/smartphone etc. to watch the videos. The videos can be watched comfortably, as it is a requirement to have "technological tools". Patients in the intervention group will be able to access the videos whenever they want. The videos will be shared only with the patients in the intervention group throughout the research. When the data collection phase is over, the videos will be shared first with the control group and then on the social media platform that hypertension patients can access.

Evaluation of data The data will be evaluated in the SPSS (Statistical Package for Social Sciences for Windows, Version 22.0) package program. In the evaluation of the data, the statistical significance value will be accepted as 0.05, the Type 1 error will be kept at 5% and the evaluation will be made with a 95% confidence interval.

Conditions
Hypertension
Being tested
Education
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationBehavioural

    Self-Management Program Conducted with Tele-Nursing will increase Treatment/Disease Adaptation, Self-Efficacy, Self-Care Management in Hypertension Patients.

Study groups in NCT05343663
Study groupRoleWhat they receive
EducationExperimentalIn the COVID-19 Pandemic, the Self-Management Program with Tele-Nursing Developed Based on the Roper Logan Tierney Model will increase Treatment/Disease Adaptation, Self-Efficacy, Self-Care Management in Hypertension Patients.
Receives: Behavioral: Education
ControlNo interventionIt will not change the Treatment/Disease Adaptation, Self-Efficacy, Self-Care Management in Hypertension Patients of the Self-Management Program Conducted by Tele-Nursing, Developed Based on the Roper Logan Tierney Model in the COVID-19 Pandemic.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hill-Bone Hypertension Treatment Adherence Scale (HBHTUS)

    The scale consists of 14 questions. On a four-point Likert scale (0=never, 1=sometimes, 2=often, and 3=always), interview (6, 7, and 8th items), medical (1, 2, 9, 10, 11, 12, 13) and 14. items) and nutrition (3, 4 and 5 items). Except for the 6th question of the scale, all of the other questions are in the form of negative questions. The total scores obtained from the scale range from 0 to 42, with a score of 0 indicating perfect adherence to treatment. A high total score from the scale indicates a decrease in adherence to treatment.

    Measured: 3months

  2. Self-Care Management Scale in Chronic Diseases (KHÖBYÖ)

    The scale consists of 35 items and is in a five-point Likert type (1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, 5 = strongly agree). Self-protection (items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23, 25-34), and social protection (1, 3, 4, 5, 7, 9, 10, 12) There are two sub-dimensions (items 13, 14, 16, 17, 21, 24 and 35). Items 3, 15, 19 and 28 in the scale are negative statements. The total scores that can be obtained from the scale vary between 35-175 points, and an increase in the score indicates that the individual's self-care management also increases.

    Measured: 3months

  3. Scale of Adjustment to Chronic Diseases (CHU)

    In the scale with three sub-dimensions and 25 items; physical adaptation, items 1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24 (maximum 55, minimum 11 points), social adaptation; Items 2, 3, 5, 7, 17, 19, and 25 (maximum 35, minimum 7 points), psychological adjustment; Items 4, 6, 8, 11, 12, 20, 21 (maximum 35, minimum 7 points) measure. The total score taken from the scale is 125. An increase in the scores obtained from the sub-dimensions and/or the whole scale means that the patients' level of compliance with the disease also increases.

    Measured: 3months

  4. The 6-item Self-Efficacy for Managing Chronic Diseases Scale(SEMCD6)

    It is an easy-to-use and effective tool for assessing the self-efficacy levels of patients with chronic diseases. The scale is rated on a 10-point scale ranging from "not at all sure" to "very sure". The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than 1 answer is given to an item and the items are consecutive, the low score is included in the calculation. If the 2 answers given are not consecutive, this item is excluded from the calculation. In order for the scale to be calculated, at least 4 items must be answered.

    Measured: 3months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Dec 2022

Resources

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
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343663
Sponsor's protocol ID
B.30.2.ATA.. 0.01.00/553
Status last verified
Jul 2024
First submitted
13 Apr 2022
Last updated
12 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with Hypertension, run by Ataturk University 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 10 inclusion and 10 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 12 Jul 2024. 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?

Hill-Bone Hypertension Treatment Adherence Scale (HBHTUS) (time frame: 3months). 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?
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 12 Jul 2024; AzTrials last refreshed its copy on 3 Nov 2026.

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