HypertensionNCT05392140
The Effect of Smart Phone Application Supported Nursing Care Program
A study testing Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. and Standart care in people with Hypertension, run by Kastamonu University.
Trial summary
Hypertension is an important public health problem in our country and in the world. For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. and Standart care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2022to 30 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 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Agreeing to participate in the research.
- Being between 45-64 years old
- At least primary school graduate
- Using antihypertensive medication for at least 6 months with the diagnosis of primary (essential) hypertension.
- Owning a smart phone
Who cannot join
- Being diagnosed with secondary hypertension Have been diagnosed with pregnancy-onset hypertension
- Hearing, seeing and understanding problems Having a diagnosis of dementia and alzheimer's
- Diagnosed with chronic kidney failure
- Being a dialysis patient
- History of myocardial infarction, stroke, diagnosis of heart failure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Smart Phone Application Supported Nursing Care Program on the Self-Management of Hypertensive Patients
Hypertension is an important public health problem in our country and in the world. For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized. The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education. It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications. Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits. The research was organized in an experimental design with pre-test post-test control group. The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province. It is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group.
Read the detailed description
Hypertension is an important public health problem in our country and in the world. For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized. The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education. It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications. Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits. The research was organized in an experimental design with pre-test post-test control group. The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province. Sample, effect size 0.25; By taking the alpha value of 0.05 and the power of 0.80, the minimum number of samples was calculated as 82. Considering that there may be data losses, it is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group. In data collection, the "Patient Information Form", "Blood pressure follow-up form" prepared by the researcher, and the adaptation to Turkish will be collected with the help of the "Drug Adherence/Compliance Self-Efficacy Scale" prepared by Gözüm and Hacıhasanoğlu in 2005. Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. After the application is started to be used, patients will be notified every two weeks for six months for the disease management process to have nutrition, exercise and doctor control processes. Patients will be able to send a message to the nurse through the application. Messages will be answered regularly on a designated day each week. The data will be collected by face-to-face interview method after necessary explanations and necessary consents are obtained by the researchers. One month after the posttest application (second data), application predicate and usage, the third data (1st follow-up) will be collected in the 3rd month, the fourth data (2nd follow-up) will be collected in the 6th month.
- Conditions
- Hypertension
- Being tested
- Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group., Standart care
- Keywords
- Nursing, Medication adherence, Hypertension
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.Behavioural
Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.
Standart careBehavioural
Standart care
| Study group | Role | What they receive |
|---|---|---|
| intervention group. | Experimental | Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. Receives: Behavioral: Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. |
| non-intervention group | Active comparator | standard care practice will continue Receives: Behavioral: Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is a difference in time (pre-test, after intervention, 1st month, 3rd month, 6th month) between intervention and control group patients' self-efficacy scale scores of adherence to drug therapy.
Drug Adherence/Compliance Self-Efficacy Scale
Measured: 0-6 month
Secondary outcomes (1)
There is a difference in time (pre-test, after the intervention, 1st month, 3rd month, 6th month) between the patients in the intervention and control groups having normal systolic and diastolic blood pressure measurements.
Blood pressure follow-up form
Measured: 0-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 May 2022 (estimated)
- Primary completion25 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The research was organized in an experimental design with pre-test post-test control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Zeynep Arabacı, Kastamonu University
- Investigators
- Zeynep ARABACI, Study chair, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392140
- Sponsor's protocol ID
- no sponsors
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smart Phone Application Supported Nursing Care Program on the Self-Management of Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05392140
- Acronym / sponsor ID
- no sponsors
- Conditions
- Hypertension
- Keywords
- Nursing, Medication adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 25 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 26 May 2022 (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.
Hypertension is an important public health problem in our country and in the world. For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized. The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education. It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications. Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits. The research was organized in an experimental design with pre-test post-test control group. The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province. It is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group.
Detailed description
Hypertension is an important public health problem in our country and in the world. For success in hypertension treatment, timely and accurate diagnosis of patients, effective implementation of lifestyle changes, timely initiation of drug therapy and effective drug compliance are emphasized. The rapid adoption of smartphone technology provides a promising platform for overcoming drug non-compliance by providing medication intake reminders, healthy lifestyle education. It is emphasized that the health belief model can be used in the self-management of the hypertension patient's health and in the regulation of services with smart phone applications. Based on these facts, this study was planned to examine the effect of the smart phone management system supported nursing care program given by the nurse to the primary hypertension patients registered in the Family Health Center on the patient's compliance with the treatment and the blood pressure staying within the target limits. The research was organized in an experimental design with pre-test post-test control group. The population of the research consists of primary hypertensive patients registered in Family Health Centers in Tosya district of Kastamonu province. Sample, effect size 0.25; By taking the alpha value of 0.05 and the power of 0.80, the minimum number of samples was calculated as 82. Considering that there may be data losses, it is planned to include a total of 102 people, 51 in the intervention and control groups, in the sample group. In data collection, the "Patient Information Form", "Blood pressure follow-up form" prepared by the researcher, and the adaptation to Turkish will be collected with the help of the "Drug Adherence/Compliance Self-Efficacy Scale" prepared by Gözüm and Hacıhasanoğlu in 2005. Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. After the application is started to be used, patients will be notified every two weeks for six months for the disease management process to have nutrition, exercise and doctor control processes. Patients will be able to send a message to the nurse through the application. Messages will be answered regularly on a designated day each week. The data will be collected by face-to-face interview method after necessary explanations and necessary consents are obtained by the researchers. One month after the posttest application (second data), application predicate and usage, the third data (1st follow-up) will be collected in the 3rd month, the fourth data (2nd follow-up) will be collected in the 6th month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research was organized in an experimental design with pre-test post-test control group.
| Arm | Type | Receives |
|---|---|---|
| intervention group. | Experimental | Behavioral: Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. |
| non-intervention group | Active comparator | Behavioral: Standart carestandard care practice will continue |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -Agreeing to participate in the research.
- Being between 45-64 years old
- At least primary school graduate
- Using antihypertensive medication for at least 6 months with the diagnosis of primary (essential) hypertension.
- Owning a smart phone
Key exclusion criteria (5 listed)
- Being diagnosed with secondary hypertension Have been diagnosed with pregnancy-onset hypertension
- Hearing, seeing and understanding problems Having a diagnosis of dementia and alzheimer's
- Diagnosed with chronic kidney failure
- Being a dialysis patient
- History of myocardial infarction, stroke, diagnosis of heart failure
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 |
|---|---|---|
| Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group.Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. | Behavioural | intervention group. |
| Standart careStandart care | Behavioural | non-intervention group |
Primary outcome
There is a difference in time (pre-test, after intervention, 1st month, 3rd month, 6th month) between intervention and control group patients' self-efficacy scale scores of adherence to drug therapy.
Time frame: 0-6 month
Drug Adherence/Compliance Self-Efficacy Scale
1 secondary outcome
There is a difference in time (pre-test, after the intervention, 1st month, 3rd month, 6th month) between the patients in the intervention and control groups having normal systolic and diastolic blood pressure measurements.
Time frame: 0-6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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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.
Zeynep ARABACI study chair
Kastamonu University
Questions about this trial
What is this clinical trial studying?
A study testing Health belief model-based smartphone-assisted nursing care program application will be installed on the phones of the patients who will be in the intervention group. and Standart care in people with Hypertension, run by Kastamonu University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeynep ARABACI (03662802259, arabacizeynep@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
There is a difference in time (pre-test, after intervention, 1st month, 3rd month, 6th month) between intervention and control group patients' self-efficacy scale scores of adherence to drug therapy. (time frame: 0-6 month). 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 26 May 2022.