<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488289</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01375</org_study_id>
    <nct_id>NCT04488289</nct_id>
  </id_info>
  <brief_title>The Föllinge Hypertension and Lifestyle Study</brief_title>
  <acronym>FIHST</acronym>
  <official_title>The Föllinge Hypertension and Lifestyle Intervention; a Comparative Study of Methods for Blood Pressure Measurement and Survey of Living Habits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ambulatory blood pressure measurement is more demanding in terms of technical equipment and&#xD;
      specially trained staff. If blood pressure measurement in a self-care room is on average&#xD;
      equivalent to the ambulatory blood pressure daytime monitoring of hypertension in primary&#xD;
      care could be simplified. We therefore want to examine patients monitored for hypertension&#xD;
      (ICD 10) with three different methods: conventional blood pressure measurement in office,&#xD;
      self-directed automated measurement and ambulatory blood pressure, starting in December 2020.&#xD;
      We will also offer an interview covering cardiovascular risk factors, at time for enrollment&#xD;
      and after 6 months. The study was approved to include 150 adult study patients (The swedish&#xD;
      ethical review authority 2020-01375), men and women, where diagnosis and treatment of&#xD;
      hypertension is relevant after a clinical evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: At present, both 24-hour ambulatory blood pressure and self-directed blood&#xD;
      pressure measurement in self-care rooms, are services provided by most Swedish primary care&#xD;
      clinics. Ambulatory measurement of blood pressure has the disadvantage of being more&#xD;
      demanding with regard to the need for advanced technical equipment and trained staff.&#xD;
&#xD;
      Identification of modifiable cardiovascular risk factors and support for change, should be&#xD;
      integrated into the treatment programs of hypertension. At study entry all study participants&#xD;
      will be invited to an interview focused on identifying modifiable cardiovascular risk&#xD;
      factors, with a follow-up interview after six months to consolidate good lifestyle choices.&#xD;
&#xD;
      Aim: If self-directed blood pressure measured in a designated self-care room gives results&#xD;
      that are on average equivalent to ambulatory blood pressure daytime, diagnosis and follow-up&#xD;
      of hypertensive patients in primary care could be simplified. The majority of patients could&#xD;
      then be cared for through self-checks., and the technically more demanding ambulatory blood&#xD;
      pressure measurement reserved for special cases. We therefore want to examine patients under&#xD;
      treatment or investigated for hypertension in primary care with three different methods:&#xD;
      conventional in-office blood pressure measurement by medical staff, ambulatory blood pressure&#xD;
      and automated measurement of blood pressure in a special self-care room. Between study entry&#xD;
      and after six months changes in modifiable risk factors are documented according to an&#xD;
      interview guide covering use of tobacco, alcohol, physical activity and food preferences,&#xD;
      with 4-6 fixed alternatives per item.&#xD;
&#xD;
      Demographics: Study patients are recruited among patients registered at Föllinge Health&#xD;
      Centre (population 1500), of which about 1000 are in ages where investigation and treatment&#xD;
      of hypertension could be relevant. The prevalence of hypertension in the adult population is&#xD;
      estimated to about 30%.&#xD;
&#xD;
      Methods: We will recruit men and women from age 20 and older. Advanced age is not a criterion&#xD;
      for exclusion if treatment of hypertension is judged to be important after clinical&#xD;
      assessment.&#xD;
&#xD;
      Power calculation: Between-methods difference 4 mm Hg, standard deviation 15, correlation&#xD;
      0.4, nominal power 0.8, alpha 0.05: Least necessary number of pairwise measurements N = 135.&#xD;
      Corresponding simulation as above, with an assumed correlation 0.5: Necessary number of&#xD;
      pairwise measurements N =113. Based on the power calculation, we want to recruit up to 150&#xD;
      study patients for self-directed and office-based blood pressure measurement and ambulatory&#xD;
      blood pressure, preliminarily starting in October 1 2020 and last enrolment December 30 2022.&#xD;
&#xD;
      Interview: An interview is offered to all study participants at enrolment and after about 6&#xD;
      months. The interview follows a risk factor inventory according to the Swedish Health&#xD;
      Promotion and Healthcare Network, and the patient information pamphlet &quot;Healthy choices make&#xD;
      a difference&quot;.&#xD;
&#xD;
      Procedures: Potential study patients provide signed informed consent before enrolling in the&#xD;
      study. Study patients are identified among patients who are evaluated or treated for&#xD;
      hypertension. Study patients who have provided written informed consent are randomised for&#xD;
      in-office and self-directed blood pressure measurement in random order on the day before and&#xD;
      immediately after completing a 24-hour ambulatory blood pressure measurement.&#xD;
&#xD;
      Technical equipment: Blood pressure measurements are performed with Omron meters (automated&#xD;
      oscillometry). In-office: Omron M7 Inteli IT (CE. 01997), certified for arm circumferences 22&#xD;
      - 42 cm. Self-care room: Omron i-Q142 (CE. 0197), certified for arm circumferences 22 - 42&#xD;
      cm. Ambulatory blood pressure measurement: Meditech ABPM-05 Blue BP-05 (CE 0120); cuff width&#xD;
      120 - 250 mm for 23 - 33 cm arm circumference and 150 - 330 mm, for 31 - 40 cm arm&#xD;
      circumference.&#xD;
&#xD;
      Office blood pressure: Measurement after five minutes of rest in a quiet environment, with&#xD;
      the patient sitting in a chair with a backrest and support for the arms. The blood pressure&#xD;
      cuff is applied to the upper arm, at the level of the heart. Three measurements are performed&#xD;
      at 1-2 minutes interval. Further measurements are made only if the first two values differ&gt;&#xD;
      10 mm Hg. The blood pressure is recorded as the average of the last two measurements.&#xD;
&#xD;
      Blood pressure in a self-care room: The measurement is performed according to the same&#xD;
      principles as in the office. The device signals if the patient does not handle it correctly.&#xD;
      Simple instructions are clearly posted in the room. During measurement only one patient may&#xD;
      stay in the self-care room at a time, without any staff present. Patients who need supervised&#xD;
      instruction are offered guidance before measuring blood pressure on their own.&#xD;
&#xD;
      Ambulatory blood pressure: measurement every 30 minutes from 06 A.M.until 22 P.M. and every&#xD;
      60 minutes at night, for a total of 24 hours. The mean value 06 A.M.- 22 P.M is compared with&#xD;
      the mean values for blood pressure measured in-office and in the self-care room respectively.&#xD;
      All blood pressure measurements are performed in the left upper arm, to be able to compare&#xD;
      with the corresponding values obtained in the self-care room, where the device is adapted for&#xD;
      measurement in the left arm, while the patient handles the device's button control with the&#xD;
      right hand.&#xD;
&#xD;
      Statistics: Standard numerical outcome measures, means and proportions for baseline&#xD;
      variables, t-test and Chi-2, for means and group comparisons, respectively.&#xD;
&#xD;
      Standard blood and urine samples are analysed at the Department of Clinical Chemistry,&#xD;
      Östersund Hospital. Potential study patients will undergo a medical examination, relevant&#xD;
      biochemical analyses and an ECG recording (12-lead standard ECG) before enrolment in the&#xD;
      study.&#xD;
&#xD;
      Importance of expected findings: Ambulatory blood pressure measurement has the disadvantage&#xD;
      of being more demanding in terms of technical equipment and specially trained staff. If blood&#xD;
      pressure measurement in a self-care room gives results that are equivalent to the ambulatory&#xD;
      blood pressure values daytime, monitoring of hypertension in primary care could be&#xD;
      simplified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparative measurement of blood pressure</measure>
    <time_frame>Hours 24</time_frame>
    <description>Systolic and diastolic pressure, in office, self directed and ambulatory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of modifiable cardiovascular risk factors</measure>
    <time_frame>Months 6</time_frame>
    <description>Modifiable risk factor scoring according to the questionnaire &quot;Goda hälsoval gör skillnad&quot; (www.hfsnatverket.se). Higher score indicating higher cardiovascular risk:&#xD;
Tobacco, cigarettes per day: never smoker; previous ≥6 months; previous &lt;6 months; daily smoker 1-9; 10-14; 15-20; &gt;20.&#xD;
Alcohol, standard glasses per week: abstainer; &lt;1; 1-4; 5-9; 10-14; ≥15 per week. (One standard glass equals 33 cm of beer or cider, 15 cl of wine or 4 cl of spirits.) Binge drinking, standard glasses; men ≥5, women ≥4: Never; &lt;1/month; every month; every week; daily or almost daily.&#xD;
Minutes of physic activity for at least 10 minutes, within 1 week: No; &lt;30; 30-60; 60-90; 90-150; 150-300; &gt; 300 minutes (5 hours or more).&#xD;
Consumption of vegetables (fresh, boiled or frozen) servings per day: ≥2; 1; 2-6 servings per week; ≤1 servings per week.&#xD;
Consumption of fruit (fresh, boiled or frozen) servings per day: ≥2; 1day; 2-6 servings per week; ≤1 servings per week.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Hypertension,Essential</condition>
  <condition>Lifestyle-related Condition</condition>
  <arm_group>
    <arm_group_label>Parallel measurement of blood pressure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Office blood pressure, self-directed and ambulatory blood pressure measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lifestyle</intervention_name>
    <description>Cardiovascular risk and lifestyle</description>
    <arm_group_label>Parallel measurement of blood pressure</arm_group_label>
    <other_name>Lifestyle intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20 years or older&#xD;
&#xD;
          -  investigated or treated because of essential hypertension&#xD;
&#xD;
          -  registered at Föllinge Health Centre&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients in need of emergency care&#xD;
&#xD;
          -  advanced stages of disease or dementia&#xD;
&#xD;
          -  not able to perform self-directed blood pressure measurement&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  atrial fibrillation&#xD;
&#xD;
          -  arm circumference to small or wide for device&#xD;
&#xD;
          -  non consenting&#xD;
&#xD;
          -  re entry in same study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gunnar Nilsson</name>
      <address>
        <city>Östersund</city>
        <state>Region Jämtland Härjedalen</state>
        <zip>831 29</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488289
org study id: 2020-01375
nct id: NCT04488289
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Background: At present, both 24-hour ambulatory blood pressure and self-directed blood
      pressure measurement in self-care rooms, are services provided by most Swedish primary care
      clinics. Ambulatory measurement of blood pressure has the disadvantage of being more
      demanding with regard to the need for advanced technical equipment and trained staff.

      Identification of modifiable cardiovascular risk factors and support for change, should be
      integrated into the treatment programs of hypertension. At study entry all study participants
      will be invited to an interview focused on identifying modifiable cardiovascular risk
      factors, with a follow-up interview after six months to consolidate good lifestyle choices.

      Aim: If self-directed blood pressure measured in a designated self-care room gives results
      that are on average equivalent to ambulatory blood pressure daytime, diagnosis and follow-up
      of hypertensive patients in primary care could be simplified. The majority of patients could
      then be cared for through self-checks., and the technically more demanding ambulatory blood
      pressure measurement reserved for special cases. We therefore want to examine patients under
      treatment or investigated for hypertension in primary care with three different methods:
      conventional in-office blood pressure measurement by medical staff, ambulatory blood pressure
      and automated measurement of blood pressure in a special self-care room. Between study entry
      and after six months changes in modifiable risk factors are documented according to an
      interview guide covering use of tobacco, alcohol, physical activity and food preferences,
      with 4-6 fixed alternatives per item.

      Demographics: Study patients are recruited among patients registered at Föllinge Health
      Centre (population 1500), of which about 1000 are in ages where investigation and treatment
      of hypertension could be relevant. The prevalence of hypertension in the adult population is
      estimated to about 30%.

      Methods: We will recruit men and women from age 20 and older. Advanced age is not a criterion
      for exclusion if treatment of hypertension is judged to be important after clinical
      assessment.

      Power calculation: Between-methods difference 4 mm Hg, standard deviation 15, correlation
      0.4, nominal power 0.8, alpha 0.05: Least necessary number of pairwise measurements N = 135.
      Corresponding simulation as above, with an assumed correlation 0.5: Necessary number of
      pairwise measurements N =113. Based on the power calculation, we want to recruit up to 150
      study patients for self-directed and office-based blood pressure measurement and ambulatory
      blood pressure, preliminarily starting in October 1 2020 and last enrolment December 30 2022.

      Interview: An interview is offered to all study participants at enrolment and after about 6
      months. The interview follows a risk factor inventory according to the Swedish Health
      Promotion and Healthcare Network, and the patient information pamphlet "Healthy choices make
      a difference".

      Procedures: Potential study patients provide signed informed consent before enrolling in the
      study. Study patients are identified among patients who are evaluated or treated for
      hypertension. Study patients who have provided written informed consent are randomised for
      in-office and self-directed blood pressure measurement in random order on the day before and
      immediately after completing a 24-hour ambulatory blood pressure measurement.

      Technical equipment: Blood pressure measurements are performed with Omron meters (automated
      oscillometry). In-office: Omron M7 Inteli IT (CE. 01997), certified for arm circumferences 22
      - 42 cm. Self-care room: Omron i-Q142 (CE. 0197), certified for arm circumferences 22 - 42
      cm. Ambulatory blood pressure measurement: Meditech ABPM-05 Blue BP-05 (CE 0120); cuff width
      120 - 250 mm for 23 - 33 cm arm circumference and 150 - 330 mm, for 31 - 40 cm arm
      circumference.

      Office blood pressure: Measurement after five minutes of rest in a quiet environment, with
      the patient sitting in a chair with a backrest and support for the arms. The blood pressure
      cuff is applied to the upper arm, at the level of the heart. Three measurements are performed
      at 1-2 minutes interval. Further measurements are made only if the first two values differ>
      10 mm Hg. The blood pressure is recorded as the average of the last two measurements.

      Blood pressure in a self-care room: The measurement is performed according to the same
      principles as in the office. The device signals if the patient does not handle it correctly.
      Simple instructions are clearly posted in the room. During measurement only one patient may
      stay in the self-care room at a time, without any staff present. Patients who need supervised
      instruction are offered guidance before measuring blood pressure on their own.

      Ambulatory blood pressure: measurement every 30 minutes from 06 A.M.until 22 P.M. and every
      60 minutes at night, for a total of 24 hours. The mean value 06 A.M.- 22 P.M is compared with
      the mean values for blood pressure measured in-office and in the self-care room respectively.
      All blood pressure measurements are performed in the left upper arm, to be able to compare
      with the corresponding values obtained in the self-care room, where the device is adapted for
      measurement in the left arm, while the patient handles the device's button control with the
      right hand.

      Statistics: Standard numerical outcome measures, means and proportions for baseline
      variables, t-test and Chi-2, for means and group comparisons, respectively.

      Standard blood and urine samples are analysed at the Department of Clinical Chemistry,
      Östersund Hospital. Potential study patients will undergo a medical examination, relevant
      biochemical analyses and an ECG recording (12-lead standard ECG) before enrolment in the
      study.

      Importance of expected findings: Ambulatory blood pressure measurement has the disadvantage
      of being more demanding in terms of technical equipment and specially trained staff. If blood
      pressure measurement in a self-care room gives results that are equivalent to the ambulatory
      blood pressure values daytime, monitoring of hypertension in primary care could be
      simplified.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparative measurement of blood pressure
time frame: Hours 24
description: Systolic and diastolic pressure, in office, self directed and ambulatory
measure: Assessment of modifiable cardiovascular risk factors
time frame: Months 6
description: Modifiable risk factor scoring according to the questionnaire "Goda hälsoval gör skillnad" (www.hfsnatverket.se). Higher score indicating higher cardiovascular risk:
Tobacco, cigarettes per day: never smoker; previous ≥6 months; previous <6 months; daily smoker 1-9; 10-14; 15-20; >20.
Alcohol, standard glasses per week: abstainer; <1; 1-4; 5-9; 10-14; ≥15 per week. (One standard glass equals 33 cm of beer or cider, 15 cl of wine or 4 cl of spirits.) Binge drinking, standard glasses; men ≥5, women ≥4: Never; <1/month; every month; every week; daily or almost daily.
Minutes of physic activity for at least 10 minutes, within 1 week: No; <30; 30-60; 60-90; 90-150; 150-300; > 300 minutes (5 hours or more).
Consumption of vegetables (fresh, boiled or frozen) servings per day: ≥2; 1; 2-6 servings per week; ≤1 servings per week.
Consumption of fruit (fresh, boiled or frozen) servings per day: ≥2; 1day; 2-6 servings per week; ≤1 servings per week.
arm group label: Parallel measurement of blood pressure
arm group type: Other
description: Office blood pressure, self-directed and ambulatory blood pressure measurement.
intervention type: Other
intervention name: Lifestyle
description: Cardiovascular risk and lifestyle
arm group label: Parallel measurement of blood pressure
other name: Lifestyle intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
sharing ipd: No