HypertensionNCT05334446
The Effect ''of Follow-up With the Mobile Application'' on Treatment Compliance in Patients With Hypertension
A study testing The Effect of the Mobile Application in people with Hypertension, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Hypertension is an important disease that generally affects the adult population, is increasing rapidly in our country and in the world, and threatens public health due to its complications. In our country, the rate of blood pressure control in patients receiving antihypertensive treatment is 53.9%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- The Effect of the Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 30 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Being followed in the outpatient clinic with the diagnosis of hypertension for the last 1 year,
- Using antihypertensive medication
- Being a smart mobile phone user,
- 18 years of age and over
- Not having any communication problems such as seeing or hearing,
- Ability to read and write
Who cannot join
- Those who lost their lives during the research,
- Those who want to leave the research voluntarily at any stage of the research,
- Patients who fill in the forms incompletely and have missing data will be excluded from the study.
- Being illiterate
- Having communication problems such as seeing and hearing,
- Not being willing to participate in the study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect on Treatment Compliance and Self-Care Management in Patients With Hypertension
Hypertension is an important disease that generally affects the adult population, is increasing rapidly in our country and in the world, and threatens public health due to its complications. In our country, the rate of blood pressure control in patients receiving antihypertensive treatment is 53.9%. One of the factors that play a role in not exceeding this rate is the patient's non-compliance with treatment.
Hypertension management has two main building blocks. These are: lifestyle improvement and drug therapy. According to the data of the World Health Organization, the rate of compliance with treatment in chronic diseases in developing countries is around 50%. Morbidity and mortality are directly related to the use of drugs in patients with hypertension, and the control of hypertension is possible with the patient's compliance with the treatment. Among the reasons for non-compliance with treatment; The side effects of drugs, the patient's insecurity about the effectiveness and benefit of the treatment, lack of motivation, the absence of disturbing physical symptoms in some patients, lack of knowledge about drug therapy and diet regimens, miscommunication between the patient and the physician, the complexity of the treatment, and insufficient participation in the follow-up of the patient can be counted. It is important to support and follow-up the hypertensive individual in order to develop their self-care skills and to adapt and maintain their lifestyle changes and drug treatment to keep their blood pressure under control.
Read more
The use of mobile health services is becoming more and more popular in the self-management of chronic diseases such as hypertension. Due to the rapid adoption of smartphone technologies, mobile phones are now attracting the attention of individuals with chronic diseases and increasing their usability, thanks to their entertaining use as well as monitoring patient data, providing personalized self-management, benefiting from social effects.
This study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control.
Read the detailed description
This research was planned as a randomized controlled study in the pre-test post-test evaluation order before and after the mobile application in order to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension".
The research was carried out between 22.11.2021-03.01.2022. It is planned to be conducted with patients who applied to the Cardiology Polyclinic of City Hospital and who were diagnosed with essential hypertension at least 1 year ago and met the research criteria.
The sample of the study, on the other hand, will consist of patients aged 18 and over, who were diagnosed at least 1 year ago, who were diagnosed with hypertension, who applied to the hypertension outpatient clinic, who were treated with antihypertensive drugs, who met the inclusion criteria of the study, and who volunteered to participate in the study. G-power program was used for power calculation of the study. Accordingly, it was calculated that at least 30 participants in each group were required for a difference of at least 5% between the control and intervention groups to be significant at the 95% confidence interval for 80% power. When the 10% loss that may occur during the follow-up of the patients is added to this number, it was planned to include at least 33 participants for both groups.
Sample selection in this study; Randomization will be performed by a person who was not involved in the study in the computer environment. Those with odd number of patient registration numbers will be Group 1: Intervention (Training Group), those with even number of patient registration numbers will be Group 2: Control Group.
Group 1: To be followed by the researchers for 4 weeks with a mobile application; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups will be monitored over the system.
Group 2: It is the control group whose routine outpatient follow-up will continue and no training is given.
Data Collection Tools to be Used in the Study: Data collection form will be collected with "Hill-Bone Hypertension Treatment Adherence Scale", "Hypertension Self-Care Profile Scale".
- Conditions
- Hypertension
- Being tested
- The Effect of the Mobile Application
- Keywords
- Hypertension, Mobile Application, Treatment Compliance, Self Care Management
- Medical subject headings
- Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of the Mobile ApplicationBehavioural
This study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control.
| Study group | Role | What they receive |
|---|---|---|
| The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension | Experimental | Intervention Group:mobile application for 4 weeks; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups is monitored over the system. Receives: Behavioral: The Effect of the Mobile Application |
| The Effect ''of Follow-up with the Mobile Application'' in Hypertension control group | No intervention | It is the control group whose routine outpatient follow-up will continue and no training is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure value
The average blood pressure values of the patients will be taken at the end of 24 hours by attaching a blood pressure holter.
Measured: 6 weeks
Hypertension Self-Care Profile Scale
Motivation of patients; It is a 20-item Likert-type scale evaluating not important=1, somewhat important=2, important=3, very important=4. The scale results in a score between 20 and 80. A higher score indicates better self-care of a patient with hypertension.
Measured: 6 weeks
Hill-Bone Hypertension Treatment Adherence Scale
The scale consists of 14 questions of 4-point Likert type. The answers include (0) "Never", (1) "Sometimes", (2) "Often" and (3) "Always". The scale total score ranges from 0 to 42. The higher the score, the lower the fit.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Nov 2021
- Primary completion15 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- The Effect ''of Follow-up With the Mobile Application'' on Treatment Compliance with the intervention group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Yıldırım Keskin, Selcuk University
- Investigators
- Alev YILDIRIM KESKİN, Asst. Prof, Principal investigator, Selcuk University/ School of Health, KONYA, TURKEY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334446
- Sponsor's protocol ID
- 2021/19
- Other IDs
- 2021/484
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5.
PubMed 30431384Kang H, Park HA. Development of Hypertension Management Mobile Application based on Clinical Practice Guidelines. Stud Health Technol Inform. 2015;210:602-6.
PubMed 25991219Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23.
PubMed 25903164Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
PubMed 26456490Cutrona SL, Choudhry NK, Fischer MA, Servi A, Liberman JN, Brennan TA, Shrank WH. Modes of delivery for interventions to improve cardiovascular medication adherence. Am J Manag Care. 2010;16(12):929-42.
PubMed 21348564Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Makitalo A. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18.
PubMed 29343156Yildirim Keskin A, Ozpancar Solpan N, Degirmenci H. The Effect of Mobile Application Follow-Up on Treatment Compliance and Self-Care Management in Patients With Hypertension: Randomized Controlled Trial. Public Health Nurs. 2025 Jan-Feb;42(1):275-285. doi: 10.1111/phn.13476. Epub 2024 Nov 4.
PubMed 39492655
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Treatment Compliance and Self-Care Management in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05334446
- Acronym / sponsor ID
- 2021/19
- Conditions
- Hypertension
- Keywords
- Hypertension, Mobile Application, Treatment Compliance, Self Care Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 19 Apr 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 disease that generally affects the adult population, is increasing rapidly in our country and in the world, and threatens public health due to its complications. In our country, the rate of blood pressure control in patients receiving antihypertensive treatment is 53.9%. One of the factors that play a role in not exceeding this rate is the patient's non-compliance with treatment.
Hypertension management has two main building blocks. These are: lifestyle improvement and drug therapy. According to the data of the World Health Organization, the rate of compliance with treatment in chronic diseases in developing countries is around 50%. Morbidity and mortality are directly related to the use of drugs in patients with hypertension, and the control of hypertension is possible with the patient's compliance with the treatment. Among the reasons for non-compliance with treatment; The side effects of drugs, the patient's insecurity about the effectiveness and benefit of the treatment, lack of motivation, the absence of disturbing physical symptoms in some patients, lack of knowledge about drug therapy and diet regimens, miscommunication between the patient and the physician, the complexity of the treatment, and insufficient participation in the follow-up of the patient can be counted. It is important to support and follow-up the hypertensive individual in order to develop their self-care skills and to adapt and maintain their lifestyle changes and drug treatment to keep their blood pressure under control.
The use of mobile health services is becoming more and more popular in the self-management of chronic diseases such as hypertension. Due to the rapid adoption of smartphone technologies, mobile phones are now attracting the attention of individuals with chronic diseases and increasing their usability, thanks to their entertaining use as well as monitoring patient data, providing personalized self-management, benefiting from social effects.
This study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control.
Detailed description
This research was planned as a randomized controlled study in the pre-test post-test evaluation order before and after the mobile application in order to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension".
The research was carried out between 22.11.2021-03.01.2022. It is planned to be conducted with patients who applied to the Cardiology Polyclinic of City Hospital and who were diagnosed with essential hypertension at least 1 year ago and met the research criteria.
The sample of the study, on the other hand, will consist of patients aged 18 and over, who were diagnosed at least 1 year ago, who were diagnosed with hypertension, who applied to the hypertension outpatient clinic, who were treated with antihypertensive drugs, who met the inclusion criteria of the study, and who volunteered to participate in the study. G-power program was used for power calculation of the study. Accordingly, it was calculated that at least 30 participants in each group were required for a difference of at least 5% between the control and intervention groups to be significant at the 95% confidence interval for 80% power. When the 10% loss that may occur during the follow-up of the patients is added to this number, it was planned to include at least 33 participants for both groups.
Sample selection in this study; Randomization will be performed by a person who was not involved in the study in the computer environment. Those with odd number of patient registration numbers will be Group 1: Intervention (Training Group), those with even number of patient registration numbers will be Group 2: Control Group.
Group 1: To be followed by the researchers for 4 weeks with a mobile application; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups will be monitored over the system.
Group 2: It is the control group whose routine outpatient follow-up will continue and no training is given.
Data Collection Tools to be Used in the Study: Data collection form will be collected with "Hill-Bone Hypertension Treatment Adherence Scale", "Hypertension Self-Care Profile Scale".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The Effect ''of Follow-up With the Mobile Application'' on Treatment Compliance with the intervention group.
| Arm | Type | Receives |
|---|---|---|
| The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension | Experimental | Behavioral: The Effect of the Mobile ApplicationIntervention Group:mobile application for 4 weeks; This is the training group in which individual motivational messages will be sent to the mobile phones every week for compliance with the diet, exercise and drug therapy of the patients, and the weekly average of blood pressure follow-ups is monitored over the system. |
| The Effect ''of Follow-up with the Mobile Application'' in Hypertension control group | No intervention | –It is the control group whose routine outpatient follow-up will continue and no training is given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate in the study,
- Being followed in the outpatient clinic with the diagnosis of hypertension for the last 1 year,
- Using antihypertensive medication
- Being a smart mobile phone user,
- 18 years of age and over
Key exclusion criteria (6 listed)
- Those who lost their lives during the research,
- Those who want to leave the research voluntarily at any stage of the research,
- Patients who fill in the forms incompletely and have missing data will be excluded from the study.
- Being illiterate
- Having communication problems such as seeing and hearing,
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 |
|---|---|---|
| The Effect of the Mobile ApplicationThis study was planned to determine the "Effect of Mobile Application Use on Treatment Adherence and Self-Care Management in Patients with Hypertension". The study was designed to improve individuals' knowledge about the disease, regular drug use, diet compliance, physical activity level, quitting smoking and alcohol if using, and weight control. | Behavioural | The Effect ''of Follow-up with the Mobile Application'' in Patients with Hypertension |
Primary outcome
Blood pressure value
Time frame: 6 weeks
The average blood pressure values of the patients will be taken at the end of 24 hours by attaching a blood pressure holter.
Hypertension Self-Care Profile Scale
Time frame: 6 weeks
Motivation of patients; It is a 20-item Likert-type scale evaluating not important=1, somewhat important=2, important=3, very important=4. The scale results in a score between 20 and 80. A higher score indicates better self-care of a patient with hypertension.
Hill-Bone Hypertension Treatment Adherence Scale
Time frame: 6 weeks
The scale consists of 14 questions of 4-point Likert type. The answers include (0) "Never", (1) "Sometimes", (2) "Often" and (3) "Always". The scale total score ranges from 0 to 42. The higher the score, the lower the fit.
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 19 Apr 2022.
- Background: PubMed 30431384Marquez Contreras E, Marquez Rivero S, Rodriguez Garcia E, Lopez-Garcia-Ramos L, Carlos Pastoriza Vilas J, Baldonedo Suarez A, Gracia Diez C, Gil Guillen V, Martell Claros N; Compliance Group of Spanish Society of Hypertension (SEH-LELHA). Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial. Curr Med Res Opin. 2019 Jan;35(1):167-173. doi: 10.1080/03007995.2018.1549026. Epub 2018 Dec 5.
- Background: PubMed 25991219Kang H, Park HA. Development of Hypertension Management Mobile Application based on Clinical Practice Guidelines. Stud Health Technol Inform. 2015;210:602-6.
- Background: PubMed 25903164Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23.
- Background: PubMed 26456490Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
- Background: PubMed 21348564Cutrona SL, Choudhry NK, Fischer MA, Servi A, Liberman JN, Brennan TA, Shrank WH. Modes of delivery for interventions to improve cardiovascular medication adherence. Am J Manag Care. 2010;16(12):929-42.
- Background: PubMed 29343156Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Makitalo A. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18.
- Derived from this study: PubMed 39492655Yildirim Keskin A, Ozpancar Solpan N, Degirmenci H. The Effect of Mobile Application Follow-Up on Treatment Compliance and Self-Care Management in Patients With Hypertension: Randomized Controlled Trial. Public Health Nurs. 2025 Jan-Feb;42(1):275-285. doi: 10.1111/phn.13476. Epub 2024 Nov 4.
- 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.
Alev YILDIRIM KESKİN, Asst. Prof principal investigator
Selcuk University/ School of Health, KONYA, TURKEY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of the Mobile Application in people with Hypertension, run by Selcuk 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 7 inclusion and 6 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 19 Apr 2022. 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?
Blood pressure value (time frame: 6 weeks). The study lists 3 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 NCT05334446, which also lists 7 linked publications.
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 19 Apr 2022.