<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/NCT04413500</url>
  </required_header>
  <id_info>
    <org_study_id>2017-04617</org_study_id>
    <nct_id>NCT04413500</nct_id>
  </id_info>
  <brief_title>iMedA: Improving MEDication Adherence Through Person-Centered Care and Adaptive Interventions</brief_title>
  <acronym>iMedA</acronym>
  <official_title>iMedA: Improving MEDication Adherence Through Person Centered Care and Adaptive Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Halmstad University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Halland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Halmstad University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to design, implement, and evaluate an adaptive personalized digital&#xD;
      intervention, to be delivered through a mobile application, to increase medication adherence&#xD;
      and self-care management for persons with hypertension. This is a collaborative project&#xD;
      between Halmstad University and Region Halland in Halland county, Sweden.&#xD;
&#xD;
      The project is divided into three steps: 1)Focus groups 2)pilot study 3)Longitudinal study.&#xD;
      The design of the study is influenced by the Intervention Mapping technique, which is used&#xD;
      for the design and development of health promotion programs. The investigators first&#xD;
      conducted a systematic review in order to detect the determinants, behaviors to change, and&#xD;
      implemented digital strategies in the previous studies. The result was drawn in the Matrix of&#xD;
      Change Objectives to facilitate the mapping. Then through focus groups, the investigators are&#xD;
      going to ascertain the needs of the Swedish context. Through what has been learned with these&#xD;
      findings, digital interventions will be designed and developed to be delivered via mobile&#xD;
      application. A pilot study is considered then to evaluate the feasibility and usability&#xD;
      testing of digital intervention. Finally, a longitudinal study is designed to evaluate the&#xD;
      effectiveness of the digital intervention in the longer term. The design is proposed to be an&#xD;
      interrupted time series (ITS) approach which is considered to be the strongest&#xD;
      quasi-experimental design that can be used to evaluate the effectiveness of an intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design of the digital intervention module is considered to follow the just-in-time&#xD;
      adaptive intervention framework (JITAI). JITAI is an intervention design aiming to provide&#xD;
      the right type/amount of support, at the right time, by adapting to an individual's&#xD;
      circumstances. It has enormous potential for promoting health behavior change, which in this&#xD;
      study is supposed to be medication compliance. Based on the JITAI's conceptual model, there&#xD;
      are the following components:&#xD;
&#xD;
        1. Decision points (DP) DP is a time when an intervention decision is made. Considering the&#xD;
           nature of JITAIs which are delivered through mobiles, DPs are much more rapidly than is&#xD;
           standard interventions. In iMedA, DP is considered to be daily and accompanied by the&#xD;
           time of medication intake question, i.e. &quot;Did the participant take the anti-hypertensive&#xD;
           medication today?&quot;.&#xD;
&#xD;
        2. Intervention options (IO) IOs are a set of possible interventions that are going to be&#xD;
           delivered at DPs. In JITAI, IOs can be various types of support (information, advice,&#xD;
           feedback, etc), source of support (mobile, nurse, physician, etc), amounts of support&#xD;
           (intensity, dose, etc), type of media/channel (phone call, SMS, etc).&#xD;
&#xD;
           From the conducted literature review, the investigators summarised all types of digital&#xD;
           interventions to hypertensive patients as:&#xD;
&#xD;
             -  Reminders for medication intake (daily), BP measurement (monthly), PA (biweekly)&#xD;
&#xD;
             -  Informational contents regarding hypertension and all its facts, consequences,&#xD;
                treatments, risks, medications and side-effects, lifestyle, and so on (text,&#xD;
                videos, etc)&#xD;
&#xD;
             -  Trends on medication intake/PA/BP/etc&#xD;
&#xD;
             -  Motivational messages&#xD;
&#xD;
        3. Distal outcomes (DO) DO is the ultimate goal that the intervention is trying to achieve.&#xD;
           In iMedA, the investigators considered primary and secondary DOs. Primarily the&#xD;
           investigators aim at improving medication adherence. Then in the long term, blood&#xD;
           pressure control is considered as secondary DOs besides the increased quality of life,&#xD;
           assessment of the lifestyle behavior (smoking, alcohol consumption, physical activity,&#xD;
           and food intake), and communicative and critical health literacy.&#xD;
&#xD;
           In order to measure MA, the investigators consider (1) self-reported medication intake&#xD;
           through a mobile app; (2) MUAH-16 which is a medication adherence questionnaire for&#xD;
           hypertension; and (3) pickups from pharmacies. The self-reported values are supposed to&#xD;
           be collected every day. MUAH-16 is measured pre- and post- intervention.&#xD;
&#xD;
           BP is considered to be measured every month. There are automatic devices in every&#xD;
           primary care center that people can go and measure their BP free of charge.&#xD;
&#xD;
           QoL and HL are measured through EQ5D and HL respectively and pre- and post-&#xD;
           intervention. Lifestyle assessments are measured (bi)weekly through self-report values.&#xD;
&#xD;
        4. Proximal outcomes (PO) POs are the short-term goals of the interventions. They can be&#xD;
           mediators and/or intermediate measures of the DOs. Medication intake rate is considered&#xD;
           to be the main PO, which is measured daily. Physical activity rate which is measured&#xD;
           (bi)weekly is another PO.&#xD;
&#xD;
           Since most of the contents are educational and they try to increase the hypertension&#xD;
           knowledge of the participants, the investigators will add a PO to measure how much their&#xD;
           knowledge has increased. The investigators consider two methods to measure it. First,&#xD;
           after showing the content, the investigators will ask &quot;Did the participant know …?&quot;.&#xD;
           Second, a simple gamification test will be designed to be delivered biweekly.&#xD;
&#xD;
           To prevent poor adherence to the interventions, it is recommended to define a few POs&#xD;
           related to intervention engagement and fatigue. Therefore, the investigators consider&#xD;
           the number of clicked interventions, number of watched videos, like/dislike feedbacks&#xD;
           per each intervention as POs related to intervention adherence and retention.&#xD;
&#xD;
        5. Tailoring variables (TV) TVs are information about the participant that are used to&#xD;
           decide when to provide which intervention. In other words, they are used to personalise&#xD;
           the interventions and make them adaptive to the individual's circumstances. They can be&#xD;
           measured actively or passively or both. Active assessments require an individual's&#xD;
           engagement in measuring, for example through self-reports, while passive assessments&#xD;
           require minimal/no individual engagement, for example through mobile phone's sensors.&#xD;
           POs are often used as TVs.&#xD;
&#xD;
           From baseline information, a few TVs can be selected including alcohol consumption,&#xD;
           smoking, specific diet (vegetarian, vegan, etc), age, and gender, in order to&#xD;
           personalise the interventions.&#xD;
&#xD;
           All of the POs are also considered as TVs. From the MUAH-16 questionnaire, the&#xD;
           investigators start to know more about individual's beliefs, barriers and behaviour&#xD;
           about medication adherence. It has four subscales regarding (1)positive attitude towards&#xD;
           healthcare and medication; (2) lack of discipline; (3) aversion towards medication; and&#xD;
           (4) active coping with health problems. Each subscale contains four questions. At the&#xD;
           beginning of the intervention, MUAH-16 questions are used as TVs. Then during the&#xD;
           intervention period, and based on the previously delivered informational contents to the&#xD;
           individual, the answers to &quot;Did the participant know …?&quot; questions will be used as TVs.&#xD;
&#xD;
        6. Decision rules (DR) DRs are the adaptation engine of JITAIs. They are used to determine&#xD;
           which IO to deliver to whom and when. They are the links between IOs and TVs.&#xD;
&#xD;
      DRs in iMedA will be probabilistic rules from experts modified by &quot;suggestions&quot; from&#xD;
      reinforcement learning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline medication adherence score at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>medication adherence score (MA) measured through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire.&#xD;
The higher score is correlated to better medication adherence. MUAH-16 has 4 subscales: 2 of them measures positive and the other 2 measures negative aspects of medication adherence. Therefore, we consider a positive score for the 2 positive subscales and negative scores to the negative ones. The result will be the final score showing the medication adherence score of the participant.&#xD;
The answers are supposed to be on a 7-point Likert scale (1: completely disagree and 7:completely agree). Therefore, the max score will be 48 and the min score will be -48.&#xD;
Based on the previous study, there has been shown a correlation between having a higher score and higher medication adherence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline Blood pressure at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Systolic and diastolic Blood Pressure (BP). The lower BP the better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline health literacy score at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>health literacy (HL) measured through the Communicative and Critical Health Literacy Scale.&#xD;
We expect to see an increase in HL through time, therefore the higher HL the better outcome.&#xD;
Considering the 5-point Likert scale , the max score will be 25 and the min score will be 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline Quality of Life at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>quality of life measured through the EuroQol- 5 Dimension (EQ5D) instrument. The higher score the better outcome.&#xD;
The answers to each of the five dimensions is between 1-3 scale. The EQ-VAS scale is between 0-100.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>medication intake rate</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>self-reported medication intake. We expect to see an increase in the medication intake rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>physical activity</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>physical activity rate. We expect to observe a higher physical activity rate.</description>
  </other_outcome>
  <other_outcome>
    <measure>change from baseline medication pickups from pharmacies at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>check the anti-hypertensive medication pickups from pharmacies. We expect that the pickups from pharmacies will increase.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>adaptive intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive various adaptive digital interventions through mobile app.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reminder</intervention_name>
    <description>A reminder to take the anti-hypertension medication with adjustable frequency.</description>
    <arm_group_label>adaptive intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational message</intervention_name>
    <description>An educational message to increase the knowledge about various facts around hypertension. The short messages are supposed to be sent based on the patient's needs.</description>
    <arm_group_label>adaptive intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational messages</intervention_name>
    <description>The motivational short messages to increase the motivational levels.</description>
    <arm_group_label>adaptive intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>showing trends</intervention_name>
    <description>Short messages contain different trends of medication intake rate, BP, physical activity rate, and so on.</description>
    <arm_group_label>adaptive intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 40-70 years old&#xD;
&#xD;
          -  have hypertension diagnosis (i.e. ICD 10 codes from I10 to I16 in the person's medical&#xD;
             history) for 1 year or more and have prescribed medications;&#xD;
&#xD;
          -  not receiving medication with unit-dose packaged (Apodos);&#xD;
&#xD;
          -  no previous stroke or myocardial infarction;&#xD;
&#xD;
          -  no psychological disorder or cognitive impairment;&#xD;
&#xD;
          -  no pregnancy-induced hypertension;&#xD;
&#xD;
          -  no insulin treatment;&#xD;
&#xD;
          -  no kidney disease defined as glomerular filtration rate (GFR) &lt;60 ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have no own smartphone&#xD;
&#xD;
          -  not understanding the Swedish language both spoken and written&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kobra Etminani</last_name>
    <role>Principal Investigator</role>
    <affiliation>Halmstad University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kobra Etminani</last_name>
    <phone>+46729773851</phone>
    <email>kobra.etminani@hh.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Slawomir Nowaczyk</last_name>
    <email>slawomir.nowaczyk@hh.se</email>
  </overall_contact_backup>
  <reference>
    <citation>Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.</citation>
    <PMID>27663578</PMID>
  </reference>
  <reference>
    <citation>Cabral AC, Castel-Branco M, Caramona M, Fernandez-Llimos F, Figueiredo IV. Developing an adherence in hypertension questionnaire short version: MUAH-16. J Clin Hypertens (Greenwich). 2018 Jan;20(1):118-124. doi: 10.1111/jch.13137. Epub 2017 Nov 24.</citation>
    <PMID>29171719</PMID>
  </reference>
  <reference>
    <citation>Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002 Aug;27(4):299-309. doi: 10.1046/j.1365-2710.2002.00430.x.</citation>
    <PMID>12174032</PMID>
  </reference>
  <results_reference>
    <citation>Etminani K, Tao Engstrom A, Goransson C, Sant'Anna A, Nowaczyk S. How Behavior Change Strategies are Used to Design Digital Interventions to Improve Medication Adherence and Blood Pressure Among Patients With Hypertension: Systematic Review. J Med Internet Res. 2020 Apr 9;22(4):e17201. doi: 10.2196/17201.</citation>
    <PMID>32271148</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Halmstad University</investigator_affiliation>
    <investigator_full_name>Kobra Etminani</investigator_full_name>
    <investigator_title>Assistant Professor at CAISR, department of ISDD, School of ITE, HH</investigator_title>
  </responsible_party>
  <keyword>hypertension</keyword>
  <keyword>digital intervention</keyword>
  <keyword>adaptive intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT04413500
org study id: 2017-04617
nct id: NCT04413500
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to design, implement, and evaluate an adaptive personalized digital
      intervention, to be delivered through a mobile application, to increase medication adherence
      and self-care management for persons with hypertension. This is a collaborative project
      between Halmstad University and Region Halland in Halland county, Sweden.

      The project is divided into three steps: 1)Focus groups 2)pilot study 3)Longitudinal study.
      The design of the study is influenced by the Intervention Mapping technique, which is used
      for the design and development of health promotion programs. The investigators first
      conducted a systematic review in order to detect the determinants, behaviors to change, and
      implemented digital strategies in the previous studies. The result was drawn in the Matrix of
      Change Objectives to facilitate the mapping. Then through focus groups, the investigators are
      going to ascertain the needs of the Swedish context. Through what has been learned with these
      findings, digital interventions will be designed and developed to be delivered via mobile
      application. A pilot study is considered then to evaluate the feasibility and usability
      testing of digital intervention. Finally, a longitudinal study is designed to evaluate the
      effectiveness of the digital intervention in the longer term. The design is proposed to be an
      interrupted time series (ITS) approach which is considered to be the strongest
      quasi-experimental design that can be used to evaluate the effectiveness of an intervention.
The design of the digital intervention module is considered to follow the just-in-time
      adaptive intervention framework (JITAI). JITAI is an intervention design aiming to provide
      the right type/amount of support, at the right time, by adapting to an individual's
      circumstances. It has enormous potential for promoting health behavior change, which in this
      study is supposed to be medication compliance. Based on the JITAI's conceptual model, there
      are the following components:

        1. Decision points (DP) DP is a time when an intervention decision is made. Considering the
           nature of JITAIs which are delivered through mobiles, DPs are much more rapidly than is
           standard interventions. In iMedA, DP is considered to be daily and accompanied by the
           time of medication intake question, i.e. "Did the participant take the anti-hypertensive
           medication today?".

        2. Intervention options (IO) IOs are a set of possible interventions that are going to be
           delivered at DPs. In JITAI, IOs can be various types of support (information, advice,
           feedback, etc), source of support (mobile, nurse, physician, etc), amounts of support
           (intensity, dose, etc), type of media/channel (phone call, SMS, etc).

           From the conducted literature review, the investigators summarised all types of digital
           interventions to hypertensive patients as:

             -  Reminders for medication intake (daily), BP measurement (monthly), PA (biweekly)

             -  Informational contents regarding hypertension and all its facts, consequences,
                treatments, risks, medications and side-effects, lifestyle, and so on (text,
                videos, etc)

             -  Trends on medication intake/PA/BP/etc

             -  Motivational messages

        3. Distal outcomes (DO) DO is the ultimate goal that the intervention is trying to achieve.
           In iMedA, the investigators considered primary and secondary DOs. Primarily the
           investigators aim at improving medication adherence. Then in the long term, blood
           pressure control is considered as secondary DOs besides the increased quality of life,
           assessment of the lifestyle behavior (smoking, alcohol consumption, physical activity,
           and food intake), and communicative and critical health literacy.

           In order to measure MA, the investigators consider (1) self-reported medication intake
           through a mobile app; (2) MUAH-16 which is a medication adherence questionnaire for
           hypertension; and (3) pickups from pharmacies. The self-reported values are supposed to
           be collected every day. MUAH-16 is measured pre- and post- intervention.

           BP is considered to be measured every month. There are automatic devices in every
           primary care center that people can go and measure their BP free of charge.

           QoL and HL are measured through EQ5D and HL respectively and pre- and post-
           intervention. Lifestyle assessments are measured (bi)weekly through self-report values.

        4. Proximal outcomes (PO) POs are the short-term goals of the interventions. They can be
           mediators and/or intermediate measures of the DOs. Medication intake rate is considered
           to be the main PO, which is measured daily. Physical activity rate which is measured
           (bi)weekly is another PO.

           Since most of the contents are educational and they try to increase the hypertension
           knowledge of the participants, the investigators will add a PO to measure how much their
           knowledge has increased. The investigators consider two methods to measure it. First,
           after showing the content, the investigators will ask "Did the participant know …?".
           Second, a simple gamification test will be designed to be delivered biweekly.

           To prevent poor adherence to the interventions, it is recommended to define a few POs
           related to intervention engagement and fatigue. Therefore, the investigators consider
           the number of clicked interventions, number of watched videos, like/dislike feedbacks
           per each intervention as POs related to intervention adherence and retention.

        5. Tailoring variables (TV) TVs are information about the participant that are used to
           decide when to provide which intervention. In other words, they are used to personalise
           the interventions and make them adaptive to the individual's circumstances. They can be
           measured actively or passively or both. Active assessments require an individual's
           engagement in measuring, for example through self-reports, while passive assessments
           require minimal/no individual engagement, for example through mobile phone's sensors.
           POs are often used as TVs.

           From baseline information, a few TVs can be selected including alcohol consumption,
           smoking, specific diet (vegetarian, vegan, etc), age, and gender, in order to
           personalise the interventions.

           All of the POs are also considered as TVs. From the MUAH-16 questionnaire, the
           investigators start to know more about individual's beliefs, barriers and behaviour
           about medication adherence. It has four subscales regarding (1)positive attitude towards
           healthcare and medication; (2) lack of discipline; (3) aversion towards medication; and
           (4) active coping with health problems. Each subscale contains four questions. At the
           beginning of the intervention, MUAH-16 questions are used as TVs. Then during the
           intervention period, and based on the previously delivered informational contents to the
           individual, the answers to "Did the participant know …?" questions will be used as TVs.

        6. Decision rules (DR) DRs are the adaptation engine of JITAIs. They are used to determine
           which IO to deliver to whom and when. They are the links between IOs and TVs.

      DRs in iMedA will be probabilistic rules from experts modified by "suggestions" from
      reinforcement learning.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change from baseline medication adherence score at 6 months
time frame: 6 months
description: medication adherence score (MA) measured through the Maastricht Utrecht Adherence in Hypertension (MUAH-16) questionnaire.
The higher score is correlated to better medication adherence. MUAH-16 has 4 subscales: 2 of them measures positive and the other 2 measures negative aspects of medication adherence. Therefore, we consider a positive score for the 2 positive subscales and negative scores to the negative ones. The result will be the final score showing the medication adherence score of the participant.
The answers are supposed to be on a 7-point Likert scale (1: completely disagree and 7:completely agree). Therefore, the max score will be 48 and the min score will be -48.
Based on the previous study, there has been shown a correlation between having a higher score and higher medication adherence.
measure: change from baseline Blood pressure at 6 months
time frame: 6 months
description: Systolic and diastolic Blood Pressure (BP). The lower BP the better outcome.
measure: change from baseline health literacy score at 6 months
time frame: 6 months
description: health literacy (HL) measured through the Communicative and Critical Health Literacy Scale.
We expect to see an increase in HL through time, therefore the higher HL the better outcome.
Considering the 5-point Likert scale , the max score will be 25 and the min score will be 5.
measure: change from baseline Quality of Life at 6 months
time frame: 6 months
description: quality of life measured through the EuroQol- 5 Dimension (EQ5D) instrument. The higher score the better outcome.
The answers to each of the five dimensions is between 1-3 scale. The EQ-VAS scale is between 0-100.
measure: medication intake rate
time frame: through study completion, an average of 6 months
description: self-reported medication intake. We expect to see an increase in the medication intake rate.
measure: physical activity
time frame: through study completion, an average of 6 months
description: physical activity rate. We expect to observe a higher physical activity rate.
measure: change from baseline medication pickups from pharmacies at 6 months
time frame: 6 months
description: check the anti-hypertensive medication pickups from pharmacies. We expect that the pickups from pharmacies will increase.
arm group label: adaptive intervention
arm group type: Experimental
description: The patients will receive various adaptive digital interventions through mobile app.
intervention type: Behavioral
intervention name: Reminder
description: A reminder to take the anti-hypertension medication with adjustable frequency.
arm group label: adaptive intervention
intervention type: Behavioral
intervention name: Educational message
description: An educational message to increase the knowledge about various facts around hypertension. The short messages are supposed to be sent based on the patient's needs.
arm group label: adaptive intervention
intervention type: Behavioral
intervention name: Motivational messages
description: The motivational short messages to increase the motivational levels.
arm group label: adaptive intervention
intervention type: Behavioral
intervention name: showing trends
description: Short messages contain different trends of medication intake rate, BP, physical activity rate, and so on.
arm group label: adaptive intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kobra Etminani
role: Principal Investigator
affiliation: Halmstad University
last name: Kobra Etminani
phone: +46729773851
email: kobra.etminani@hh.se
last name: Slawomir Nowaczyk
email: slawomir.nowaczyk@hh.se
citation: Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
PMID: 27663578
citation: Cabral AC, Castel-Branco M, Caramona M, Fernandez-Llimos F, Figueiredo IV. Developing an adherence in hypertension questionnaire short version: MUAH-16. J Clin Hypertens (Greenwich). 2018 Jan;20(1):118-124. doi: 10.1111/jch.13137. Epub 2017 Nov 24.
PMID: 29171719
citation: Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002 Aug;27(4):299-309. doi: 10.1046/j.1365-2710.2002.00430.x.
PMID: 12174032
citation: Etminani K, Tao Engstrom A, Goransson C, Sant'Anna A, Nowaczyk S. How Behavior Change Strategies are Used to Design Digital Interventions to Improve Medication Adherence and Blood Pressure Among Patients With Hypertension: Systematic Review. J Med Internet Res. 2020 Apr 9;22(4):e17201. doi: 10.2196/17201.
PMID: 32271148
responsible party type: Principal Investigator
investigator affiliation: Halmstad University
investigator full name: Kobra Etminani
investigator title: Assistant Professor at CAISR, department of ISDD, School of ITE, HH
mesh term: Hypertension
sharing ipd: No