HypertensionNCT06228417
A Mobile App for Medication Adherence in Persons With Hypertension: a Pilot Study
An observational study of Hypertension, run by Halmstad University at 1 site in Sweden.
Trial summary
A development and pilot test of an app targeting persons with hypertension. Content in the app was based on persons with hypertensions experiences and a literature review. The participants experience of using the app as well as testing a instrument for medication adherence. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Adaptive digital intervention
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- 23 Feb 2020to 1 Mar 2021
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with hypertension, more than one year, were enrolled. From primary care.
Who may be able to join
- 40-70 years of age,
- have hypertension (i.e., ICD 10 codes I10-I15 in the person's medical history) for ≥1 year
- have been prescribed medications to treat said hypertension
- speak and understand Swedish
- have a smartphone
Who cannot join
- having received medication with unit-dose packages (Apodos)
- previous stroke
- previous myocardial infarction
- psychological disorder or cognitive impairment (i.e. ICD 10 codes F01-F99)
- pregnancy-induced hypertension´
- insulin treatment
- kidney disease, defined as glomerulus filtration rate (GFR) <60 ml/min.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Digital Interventions Through Mobile App for Medication Adherence Improvement in Persons With Hypertension: a Pilot Study for Usability
A development and pilot test of an app targeting persons with hypertension. Content in the app was based on persons with hypertensions experiences and a literature review. The participants experience of using the app as well as testing a instrument for medication adherence.
- Conditions
- Hypertension
- Being tested
- Adaptive digital intervention
- Keywords
- artificial intelligence, focus group, adherence, medication, pilot study
- 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.
Adaptive digital interventionOther
Participants received reminder for medication intake on daily basis. Also, short message regarding hypertension, medication and lifestyle changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence measured by the participants self-reported intake of daily medication in the app.
The usage is described in frequencies and response time.
Measured: two weeks
Adherence hypertension medication
Medication score through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire.
The questionnaire consists of four subscales: two of them measures positive and two others measures negative aspects of attitudes to medication adherence and health problem. Min value for each subscale are 4 and maximum 28. Higher value indicate better outcome
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start23 Feb 2020
- Primary completion27 Feb 2021
- Study completion1 Mar 2021
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halmstad University
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova
- Responsible party
- Principal investigator, Slawomir Nowaczyk, Halmstad University
- Investigators
- Slawomir Nowaczyk, Professor, Principal investigator, Halmstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228417
- Sponsor's protocol ID
- 2017_04617
- Other IDs
- 2017
- Status last verified
- Mar 2024
- First submitted
- 27 Dec 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only researchers included in the study the will have access.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Digital Interventions Through Mobile App for Medication Adherence Improvement in Persons With Hypertension: a Pilot Study for Usability
- ClinicalTrials.gov ID
- NCT06228417
- Acronym / sponsor ID
- 2017_04617
- Conditions
- Hypertension
- Keywords
- artificial intelligence, focus group, adherence, medication, pilot study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Halmstad UniversityUniversity, hospital or other
- Collaborators
- Vinnova
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 29 Jan 2024 (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.
A development and pilot test of an app targeting persons with hypertension. Content in the app was based on persons with hypertensions experiences and a literature review. The participants experience of using the app as well as testing a instrument for medication adherence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with hypertension, more than one year, were enrolled. From primary care.
Key inclusion criteria (5 listed)
- 40-70 years of age,
- have hypertension (i.e., ICD 10 codes I10-I15 in the person's medical history) for ≥1 year
- have been prescribed medications to treat said hypertension
- speak and understand Swedish
- have a smartphone
Key exclusion criteria (7 listed)
- having received medication with unit-dose packages (Apodos)
- previous stroke
- previous myocardial infarction
- psychological disorder or cognitive impairment (i.e. ICD 10 codes F01-F99)
- pregnancy-induced hypertension´
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 |
|---|---|---|
| Adaptive digital interventionParticipants received reminder for medication intake on daily basis. Also, short message regarding hypertension, medication and lifestyle changes | Other | – |
Primary outcome
Medication adherence
Time frame: two weeks
Medication adherence measured by the participants self-reported intake of daily medication in the app. The usage is described in frequencies and response time.
Adherence hypertension medication
Time frame: two weeks
Medication score through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire. The questionnaire consists of four subscales: two of them measures positive and two others measures negative aspects of attitudes to medication adherence and health problem. Min value for each subscale are 4 and maximum 28. Higher value indicate better outcome
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 Mar 2024.
- Individual participant dataSharing planned: Undecided. Only researchers included in the study the will have access.
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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.
Slawomir Nowaczyk, Professor principal investigator
Halmstad University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Halmstad University at 1 site in Sweden.
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 7 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 Mar 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 Sweden. 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?
Medication adherence (time frame: two weeks). 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 19 Mar 2024.