NCT06228417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

December 27, 2023

Last Update Submit

March 16, 2024

Conditions

Keywords

artificial intelligencefocus groupadherence, medicationpilot study

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    two weeks

Interventions

Participants received reminder for medication intake on daily basis. Also, short message regarding hypertension, medication and lifestyle changes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with hypertension, more than one year, were enrolled. From primary care.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halmstad University

Halmstad, Sweden

Location

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Slawomir Nowaczyk, Professor

    Halmstad University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 29, 2024

Study Start

February 23, 2020

Primary Completion

February 27, 2021

Study Completion

March 1, 2021

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations