High Blood PressureNCT04554147
Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
A study testing FAITH! App-enhanced Hypertension Intervention in people with High Blood Pressure, run by Mayo Clinic at 3 sites in United States.
Trial summary
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- FAITH! App-enhanced Hypertension Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2021to 30 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American race/ethnicity
- 18 years or older
- Receive primary care at one of the two partnering Federally Qualified Health Centers (FQHC) and intent to continue care there for next 6 months
- Uncontrolled HTN (defined as BP ≥140/90 mmHg [as per JNC7 Hypertension Guidelines68] at most recent outpatient evaluation, with or without BP medications)
- Documented diagnosis of HTN in EHR
- At least 1 office visit at one of the two partnering FQHCs in prior year
- Smartphone ownership (supporting iOS or Android Systems)
Who cannot join
- Unable to commit to participating in both focus groups (pre and post app refinement).
- Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
North Point Health & Wellness Center
Minneapolis, Minnesota, 55411
Mayo Clinic
Rochester, Minnesota, 55905
Open Cities Health Center
Saint Paul, Minnesota, 55104
About this study
Official title: Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers.
Read the detailed description
The Fostering African-American Improvement in Total Health (FAITH!) Program at Mayo Clinic, a community-based cardiovascular (CV) health promotion initiative for African-Americans (AAs) will collaborate with the Minnesota Department of Health (MDH) Cardiovascular Health Unit and two federally qualified health centers (FQHCs) (NorthPoint Health \& Wellness Center, Minneapolis, MN; Open Cities Health Center, St. Paul, MN) to integrate an innovative mobile health (mHealth) intervention (FAITH! HTN App) into clinical and community settings with the aim of improving blood pressure (BP) control.
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers. This initiative is a component of a Centers for Disease Control and Prevention (CDC) effort to support state/local public health strategies to prevent and manage cardiovascular disease (CVD) in under-resourced populations disproportionately affected by CVD risk factors, such as HTN. Insights from the FAITH! Community Steering Committee (CSC) will also provide guidance to ensure project patient-centeredness. The investigators will incorporate strategies grounded in theoretical frameworks to ensure soundness of our intervention while tailoring it to meet the preferences and needs of an under-resourced population with multi-level barriers to HTN management.
Specific Aim 1:To assess app feasibility through participant intervention engagement (app education module completion, self-monitoring) and intervention satisfaction.
Specific Aim 2: To assess preliminary efficacy of the app by evaluating improvement in patient BP control (immediate, 3 months and 6 months post-intervention), CV health knowledge (via app self-assessments), and BP self-management (medication adherence).
Hypothesis:
The study hypothesis is that an app-based intervention will be feasible and demonstrate preliminary efficacy in improving uncontrolled HTN and health education among AA patients from baseline to post-intervention (immediate, 3 months and 6 months post-intervention).
- Conditions
- High Blood Pressure
- Being tested
- FAITH! App-enhanced Hypertension Intervention
- Keywords
- health disparities, mobile health, community health, African-Americans
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAITH! App-enhanced Hypertension InterventionBehavioural
FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management.
Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention.
| Study group | Role | What they receive |
|---|---|---|
| FAITH! App-enhanced Hypertension Intervention | Experimental | FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management.
Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention. Receives: Behavioral: FAITH! App-enhanced Hypertension Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
Measured: 0 months post intervention
Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
Measured: 3 months post intervention
Blood pressure (systolic and diastolic, mmHg)
Change from baseline blood pressure.
Measured: 6 months post intervention
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Measured: Immediate post-intervention
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Measured: Time Frame: 3 months post-intervention
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Measured: Time Frame: 6 months post-intervention
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Measured: Immediate post-intervention
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Measured: 3 months post-intervention
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
Measured: 6 months post-intervention
Secondary outcomes (4)
Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores
Change in percentage correct scores (pre- and post- self-assessments) for each education module by patient and as a conglomerate (mean) for all patients.
Measured: Immediate post intervention
Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)
Change from baseline PRAPARE score. The PRAPARE assessment tool will be used to calculate a tally risk score indicating the cumulative number of SDOH risks a patient faces (including 15 SDOH domains).
Measured: Immediate post-intervention
Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management
Change from baseline score. Self-efficacy to change health behaviors to manage HTN as measured by a 5-item instrument.
Measured: Immediate post-intervention
Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)
Change from baseline score. The 13-item instrument assesses patients' confidence in their ability to take their BP medications in a variety of situations.
Measured: Immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Apr 2021
- Primary completion25 Aug 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a nonrandomized, single arm feasibility study testing the preliminary efficacy of an app-enhanced intervention with a patient-provider-community health worker triad to promote hypertension control among AA patients within FQHCs.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LaPrincess C. Brewer, Mayo Clinic
- Investigators
- LaPrincess C Brewer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554147
- Sponsor's protocol ID
- 19-009247
- Status last verified
- Apr 2024
- First submitted
- 12 Jul 2020
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brewer LC, Jones C, Slusser JP, Pasha M, Lalika M, Chacon M, Takawira P, Shanedling S, Erickson P, Woods C, Krogman A, Ferdinand D, Underwood P, Cooper LA, Patten CA, Hayes SN. mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App. JMIR Form Res. 2023 Jun 16;7:e45061. doi: 10.2196/45061.
PubMed 37115658
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension Among African-Americans
- ClinicalTrials.gov ID
- NCT04554147
- Acronym / sponsor ID
- 19-009247
- Conditions
- High Blood Pressure
- Keywords
- health disparities, mobile health, community health, African-Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Sep 2020 (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.
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers.
Detailed description
The Fostering African-American Improvement in Total Health (FAITH!) Program at Mayo Clinic, a community-based cardiovascular (CV) health promotion initiative for African-Americans (AAs) will collaborate with the Minnesota Department of Health (MDH) Cardiovascular Health Unit and two federally qualified health centers (FQHCs) (NorthPoint Health \& Wellness Center, Minneapolis, MN; Open Cities Health Center, St. Paul, MN) to integrate an innovative mobile health (mHealth) intervention (FAITH! HTN App) into clinical and community settings with the aim of improving blood pressure (BP) control.
The project objective is to test the feasibility of delivering health education and self-management support to African-American patients with uncontrolled hypertension (HTN) through a culturally-tailored smartphone application (app)-enhanced intervention within federally qualified health centers. This initiative is a component of a Centers for Disease Control and Prevention (CDC) effort to support state/local public health strategies to prevent and manage cardiovascular disease (CVD) in under-resourced populations disproportionately affected by CVD risk factors, such as HTN. Insights from the FAITH! Community Steering Committee (CSC) will also provide guidance to ensure project patient-centeredness. The investigators will incorporate strategies grounded in theoretical frameworks to ensure soundness of our intervention while tailoring it to meet the preferences and needs of an under-resourced population with multi-level barriers to HTN management.
Specific Aim 1:To assess app feasibility through participant intervention engagement (app education module completion, self-monitoring) and intervention satisfaction.
Specific Aim 2: To assess preliminary efficacy of the app by evaluating improvement in patient BP control (immediate, 3 months and 6 months post-intervention), CV health knowledge (via app self-assessments), and BP self-management (medication adherence).
Hypothesis:
The study hypothesis is that an app-based intervention will be feasible and demonstrate preliminary efficacy in improving uncontrolled HTN and health education among AA patients from baseline to post-intervention (immediate, 3 months and 6 months post-intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a nonrandomized, single arm feasibility study testing the preliminary efficacy of an app-enhanced intervention with a patient-provider-community health worker triad to promote hypertension control among AA patients within FQHCs.
| Arm | Type | Receives |
|---|---|---|
| FAITH! App-enhanced Hypertension Intervention | Experimental | Behavioral: FAITH! App-enhanced Hypertension InterventionFAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management. Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American race/ethnicity
- 18 years or older
- Receive primary care at one of the two partnering Federally Qualified Health Centers (FQHC) and intent to continue care there for next 6 months
- Uncontrolled HTN (defined as BP ≥140/90 mmHg [as per JNC7 Hypertension Guidelines68] at most recent outpatient evaluation, with or without BP medications)
- Documented diagnosis of HTN in EHR
Key exclusion criteria (2 listed)
- Unable to commit to participating in both focus groups (pre and post app refinement).
- Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app).
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 |
|---|---|---|
| FAITH! App-enhanced Hypertension InterventionFAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management. Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention. | Behavioural | FAITH! App-enhanced Hypertension Intervention |
Primary outcome
Blood pressure (systolic and diastolic, mmHg)
Time frame: 0 months post intervention
Change from baseline blood pressure.
Blood pressure (systolic and diastolic, mmHg)
Time frame: 3 months post intervention
Change from baseline blood pressure.
Blood pressure (systolic and diastolic, mmHg)
Time frame: 6 months post intervention
Change from baseline blood pressure.
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Time frame: Immediate post-intervention
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Time frame: Time Frame: 3 months post-intervention
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
Intervention Feasibility Measures - Participant Engagement with Self-Monitoring
Time frame: Time Frame: 6 months post-intervention
Participant engagement with weekly blood pressure tracking measured by number of times participant engaged with the blood pressure feature
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Time frame: Immediate post-intervention
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Time frame: 3 months post-intervention
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
HTN Self-Care Measures - Participant HTN self-care activities using the H-SCALE (Hypertension Self-Care Activity Level Effects)
Time frame: 6 months post-intervention
The 31-item instrument assess 6 HTN behavioral self-care activities recommended for optimal HTN management
4 secondary outcomes
Preliminary Efficacy of Intervention - CV Health Knowledge as measured by module assessment scores
Time frame: Immediate post intervention
Social Determinants of Health (SDOH, PRAPARE (Protocol for Responding to and Addressing Patient Assets, Risks, and Experiences) tool)
Time frame: Immediate post-intervention
Preliminary Efficacy of Intervention - BP Self-Management: Self-efficacy for HTN management
Time frame: Immediate post-intervention
Self Efficacy for Medication Adherence as measured by the MASES scale (medication adherence self-efficacy scale)
Time frame: Immediate post-intervention
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 Apr 2024.
- Derived from this study: PubMed 37115658Brewer LC, Jones C, Slusser JP, Pasha M, Lalika M, Chacon M, Takawira P, Shanedling S, Erickson P, Woods C, Krogman A, Ferdinand D, Underwood P, Cooper LA, Patten CA, Hayes SN. mHealth Intervention for Promoting Hypertension Self-management Among African American Patients Receiving Care at a Community Health Center: Formative Evaluation of the FAITH! Hypertension App. JMIR Form Res. 2023 Jun 16;7:e45061. doi: 10.2196/45061.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
LaPrincess C Brewer, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAITH! App-enhanced Hypertension Intervention in people with High Blood Pressure, run by Mayo Clinic at 3 sites in United States.
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 7 inclusion and 2 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 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Blood pressure (systolic and diastolic, mmHg) (time frame: 0 months post intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554147, which also lists 1 linked publication.
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 Apr 2024.