The Föllinge Hypertension and Lifestyle Study
FIHST
1 other identifier
interventional
117
1 country
1
Brief Summary
Ambulatory blood pressure measurement is more demanding in terms of technical equipment and specially trained staff. If blood pressure measurement in a self-care room is on average equivalent to the ambulatory blood pressure daytime monitoring of hypertension in primary care could be simplified. We therefore want to examine patients monitored for hypertension (ICD 10) with three different methods: conventional blood pressure measurement in office, self-directed automated measurement and ambulatory blood pressure, starting in December 2020. We will also offer an interview covering cardiovascular risk factors, at time for enrollment and after 6 months. The study was approved to include 150 adult study patients (The swedish ethical review authority 2020-01375), men and women, where diagnosis and treatment of hypertension is relevant after a clinical evaluation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 15, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedDecember 8, 2023
December 1, 2023
2.9 years
July 15, 2020
December 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Comparative measurement of blood pressure
Systolic and diastolic pressure, in office, self directed and ambulatory
Hours 24
Secondary Outcomes (1)
Assessment of modifiable cardiovascular risk factors
Months 6
Study Arms (1)
Parallel measurement of blood pressure
OTHEROffice blood pressure, self-directed and ambulatory blood pressure measurement.
Interventions
Cardiovascular risk and lifestyle
Eligibility Criteria
You may qualify if:
- age 20 years or older
- investigated or treated because of essential hypertension
- registered at Föllinge Health Centre
You may not qualify if:
- patients in need of emergency care
- advanced stages of disease or dementia
- not able to perform self-directed blood pressure measurement
- pregnancy
- atrial fibrillation
- arm circumference to small or wide for device
- non consenting
- re entry in same study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
Study Sites (1)
Gunnar Nilsson
Östersund, Region Jämtland Härjedalen, 831 29, Sweden
Related Publications (1)
Nilsson G, Lindam A. A comparative trial of blood pressure monitoring in a self-care kiosk, in office, and with ambulatory blood pressure monitoring. BMC Cardiovasc Disord. 2024 Jan 3;24(1):27. doi: 10.1186/s12872-023-03701-1.
PMID: 38172659DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2020
First Posted
July 27, 2020
Study Start
February 1, 2021
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
December 8, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share