HypertensionNCT05728723
The Effectiveness of the Android Application as a Pharmaceutical Education Tool in Hypertensive Patients
A study testing Android Application and Pharmacy education in people with Hypertension, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Hypertension is a worldwide public health challenge due to its high prevalence and along with increased risk of complications of other diseases that are more dangerous if not managed properly. An estimated 1.4 billion people worldwide have high blood pressure, but only 14% can control it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Android Application and Pharmacy education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Mar 2023to 16 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years, male and female who are willing to be respondents.
- Patients diagnosed with hypertension or currently taking ≥ 1 antihypertensive drug.
- Hypertension patients who carry out routine control and receive anti-hypertensive drugs for at least 3 months at the Health Center.
- Not illiterate and owns a smartphone.
- Patients who are willing to participate in the study by signing an informed consent.
Who cannot join
- Physical and mental disabilities such as deaf, blind, and psychiatric disorders.
- The patient is pregnant
- Currently taking hormonal drugs and other routine drugs such as TB, HIV and AIDS drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Android Application as a Pharmaceutical Education Tool on Knowledge, Adherence, Clinical Outcome and Quality of Life of Hypertension Prolanis Patients: A Pilot Study
Hypertension is a worldwide public health challenge due to its high prevalence and along with increased risk of complications of other diseases that are more dangerous if not managed properly. An estimated 1.4 billion people worldwide have high blood pressure, but only 14% can control it. Knowledge of hypertension in patients with hypertension can prevent complications through hypertension treatment. Increasing knowledge can be done by providing education in the form of counseling by pharmacists to hypertensive patients. Counseling activities carried out by pharmacists can be supported by a technological approach. One of the uses in smartphone technology is by creating an android-based mobile application that can be developed to support pharmaceutical care. Education conducted by pharmacists can increase knowledge that will affect hypertension treatment adherence, and this education can also improve blood pressure control so that it can improve the quality of life. The purpose of this study is to analyze the influence of the android application as a standard pharmacist education tool on knowledge as well as adherence and therapeutic outcomes of hypertensive patients, and quality of life related to the health of hypertensive patients compared to just providing standard education by pharmacists to hypertensive patients at the Primary Health Care. The method used in this study is a Quasi-Experimental with Pretest - Posttest Control Group Design. Samples were obtained by purposive sampling method at the selected Primary Health Care as the intervention group and the selected Primary Health Care as the control group. Pharmacist provides education to intervention groups with android applications as counseling aids and in control groups only standard counseling is provided. Pre-test data collection was done by taking primary and secondary data of patients at the first meeting and post-test data collection was taken prospectively through face-to-face interviews and questionnaires on hypertensive patients participants for three months by observing the influence of android applications as counseling aids on knowledge of hypertensive diseases, adherence to antihypertensive treatment, outcome therapy and quality of life.
- Conditions
- Hypertension
- Being tested
- Android Application, Pharmacy education
- Keywords
- Knowledge, Adherence, Quality of Life, Smartphone, Pharmacist
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Android ApplicationDevice
Android Application for 3 months
Pharmacy educationBehavioural
Pharmacy education in hypertensive patients
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pharmacy Education with Android Application as a Tool Conducted for Three Months in Hypertensive Patients to Improve Knowledge, Adherence, Outcome Therapy and Quality of Life Receives: Device: Android Application; Behavioral: Pharmacy education |
| Pharmacy education | Active comparator | Pharmacy education in hypertensive patients Receives: Behavioral: Pharmacy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about hypertension
Measured by Hypertension Knowledge-Level Scale (HK-LS) questionnaires
Measured: At day 90 after treatment
Adherence to antihypertensive treatment
Measurement by Medication Adherence Report Scale (MARS) questionnaires
Measured: At day 90 after treatment
Secondary outcomes (2)
Blood pressure
Measurement by blood pressure measuring device.
Measured: 90 days
Quality of life related to the health
Measurement by Short Form-36 (SF-36) questionnaires
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start16 Mar 2023
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul K Tasib, S.Si., Apt., Principal investigator, Faculty of Pharmacy Universitas Padjadjaran BandungEli Halimah, Dr.M.Si.Apt., Principal investigator, Faculty of Pharmacy Universitas Padjadjaran BandungIrma M Puspitasari, Prof.MT.Ph.D, Principal investigator, Faculty of Pharmacy Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728723
- Sponsor's protocol ID
- Pharm-202301.01
- Status last verified
- Jul 2023
- First submitted
- 5 Feb 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Android Application as a Pharmaceutical Education Tool on Knowledge, Adherence, Clinical Outcome and Quality of Life of Hypertension Prolanis Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT05728723
- Acronym / sponsor ID
- Pharm-202301.01
- Conditions
- Hypertension
- Keywords
- Knowledge, Adherence, Quality of Life, Smartphone, Pharmacist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 15 Feb 2023 (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 a worldwide public health challenge due to its high prevalence and along with increased risk of complications of other diseases that are more dangerous if not managed properly. An estimated 1.4 billion people worldwide have high blood pressure, but only 14% can control it. Knowledge of hypertension in patients with hypertension can prevent complications through hypertension treatment. Increasing knowledge can be done by providing education in the form of counseling by pharmacists to hypertensive patients. Counseling activities carried out by pharmacists can be supported by a technological approach. One of the uses in smartphone technology is by creating an android-based mobile application that can be developed to support pharmaceutical care. Education conducted by pharmacists can increase knowledge that will affect hypertension treatment adherence, and this education can also improve blood pressure control so that it can improve the quality of life. The purpose of this study is to analyze the influence of the android application as a standard pharmacist education tool on knowledge as well as adherence and therapeutic outcomes of hypertensive patients, and quality of life related to the health of hypertensive patients compared to just providing standard education by pharmacists to hypertensive patients at the Primary Health Care. The method used in this study is a Quasi-Experimental with Pretest - Posttest Control Group Design. Samples were obtained by purposive sampling method at the selected Primary Health Care as the intervention group and the selected Primary Health Care as the control group. Pharmacist provides education to intervention groups with android applications as counseling aids and in control groups only standard counseling is provided. Pre-test data collection was done by taking primary and secondary data of patients at the first meeting and post-test data collection was taken prospectively through face-to-face interviews and questionnaires on hypertensive patients participants for three months by observing the influence of android applications as counseling aids on knowledge of hypertensive diseases, adherence to antihypertensive treatment, outcome therapy and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Android Application, Behavioral: Pharmacy educationPharmacy Education with Android Application as a Tool Conducted for Three Months in Hypertensive Patients to Improve Knowledge, Adherence, Outcome Therapy and Quality of Life |
| Pharmacy education | Active comparator | Behavioral: Pharmacy educationPharmacy education in hypertensive patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years, male and female who are willing to be respondents.
- Patients diagnosed with hypertension or currently taking ≥ 1 antihypertensive drug.
- Hypertension patients who carry out routine control and receive anti-hypertensive drugs for at least 3 months at the Health Center.
- Not illiterate and owns a smartphone.
- Patients who are willing to participate in the study by signing an informed consent.
Key exclusion criteria (3 listed)
- Physical and mental disabilities such as deaf, blind, and psychiatric disorders.
- The patient is pregnant
- Currently taking hormonal drugs and other routine drugs such as TB, HIV and AIDS drugs.
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 |
|---|---|---|
| Android ApplicationAndroid Application for 3 months | Device | Intervention group |
| Pharmacy educationPharmacy education in hypertensive patients | Behavioural | Intervention group, Pharmacy education |
Primary outcome
Knowledge about hypertension
Time frame: At day 90 after treatment
Measured by Hypertension Knowledge-Level Scale (HK-LS) questionnaires
Adherence to antihypertensive treatment
Time frame: At day 90 after treatment
Measurement by Medication Adherence Report Scale (MARS) questionnaires
2 secondary outcomes
Blood pressure
Time frame: 90 days
Quality of life related to the health
Time frame: 90 days
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 15 Aug 2023.
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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.
Abdul K Tasib, S.Si., Apt. principal investigator
Faculty of Pharmacy Universitas Padjadjaran Bandung
Eli Halimah, Dr.M.Si.Apt. principal investigator
Faculty of Pharmacy Universitas Padjadjaran Bandung
Irma M Puspitasari, Prof.MT.Ph.D principal investigator
Faculty of Pharmacy Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Android Application and Pharmacy education in people with Hypertension, run by Universitas Padjadjaran at 1 site in Indonesia.
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 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 15 Aug 2023. 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 Indonesia. 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?
Knowledge about hypertension (time frame: At day 90 after treatment). The study lists 2 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 15 Aug 2023.