Uncontrolled HypertensionNCT03577990
Technology Coaching Intervention for Black Women With Hypertension
A study testing Interactive Technology Enhanced Coaching (ITEC) and Interactive Technology-No Coaching (IT) in people with Uncontrolled Hypertension, run by University of North Carolina, Charlotte at 1 site in United States.
Trial summary
Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- Interactive Technology Enhanced Coaching (ITEC) and Interactive Technology-No Coaching (IT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2019to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as Black or African American;
- 18-70 years of age
- English speaking
- Has to live in the study community, Charlotte or surrounding area
- Systolic BP greater than or equal to 130 and/or diastolic BP greater than or equal to 80 at screening
- Prescribed to take one or more antihypertensive medication(s)
- Smartphone or device
- Bluetooth 4.0 and Provider network or Wi-Fi connectivity
Who cannot join
- Self-report of mental illness that interferes with daily functioning
- Unable to be physically active
- Current pregnancy
- Plans to move from the study area during the project
- Systolic BP greater than or equal to 160 and/or diastolic BP greater than or equal to 100
- Uncontrolled diabetes (HbA1c >8.5), hemodialysis, stroke (within past year with residual effects such as weakness, paralysis, speech difficulty, etc.), cancer treatment (for spread of cancer to other places in the body), or a heart attack (within the past year)
- Concurrent participation in another research study and/or taken any Stanford self-management program
Trial locations and contacts
1 site in 1 country.
United States1 site
Churches, Salons, Community Events
Charlotte, North Carolina, 28223
About this study
Official title: An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension
Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.
Read the detailed description
This study includes a sample of community dwelling Black women with uncontrolled HTN. All participants meeting study eligibility requirements will receive the Chronic Disease Self-Management Program (CDSMP) workshop for 6 weeks. Participants from this pool will be randomized to the treatment and control arm. All study participants will continue to receive usual care for their HTN.
The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm will receive electronic monitoring (of participants' BP, weight, physical activity, food diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC) while the control arm will receive usual care with manual BP measurements monthly. At Step 2 for three months, the treatment arm will receive electronic monitoring with ITEC biweekly, and the control arm will receive electronic monitoring only. At Step 3 for three months, both the treatment arm and the control arm will receive electronic monitoring only.
Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic measurements, anthropometric measurements, and data collection tools) at baseline, 3 months, 6 months, and at 9 months post CDSMP. A hierarchical, mixed-effects repeated measures design will be used to analyze the data.
The project is a two-arm randomized controlled trial with specific aims to determine whether the effects of CDSMP combined with ITEC will maintain BP control, attain medication adherence, and achieve lifestyle modifications (physical activity, diet, and weight management) compared to the CDSMP alone. We will test the hypothesis that:
- More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in CDSMP alone.
- More participants in the CDSMP/ITEC arm will have higher levels of adherence to antihypertensive medication(s) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
- More participants in the CDSMP/ITEC arm, will have higher levels of adherence to lifestyle modifications (physical activity, diet, and weight management) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
Information from this study may be used to enhance self-care management, control blood pressure, and increase the quality of life for Black women who are burdened with the adverse effects of HTN and its high disability and mortality rates.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Interactive Technology Enhanced Coaching (ITEC), Interactive Technology-No Coaching (IT)
- Keywords
- hypertension, Black women, self-management, coaching
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Technology Enhanced Coaching (ITEC)Behavioural
As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Interactive Technology-No Coaching (IT)Behavioural
After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Experimental | Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability. Receives: Behavioral: Interactive Technology Enhanced Coaching (ITEC) |
| Interactive Technology-No Coaching (IT) | Active comparator | Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm. Receives: Behavioral: Interactive Technology-No Coaching (IT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and Diastolic Blood Pressure (BP)
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
Measured: Baseline to 3 months, 6 months, and 9 months.
Secondary outcomes (5)
Medication Adherence by Proportion of Days Covered
To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100.
Measured: Month 1 to Month 3, Month 6, and Month 9.
Physical Activity (Change in Daily Steps)
To show the change (increase) in daily steps over 9 months.
Measured: Month 1 to Month 3, Month 6, and Month 9.
Change in Dietary Intake (Calories)
To show the change (decrease) in dietary intake (calories) over 9 months.
Measured: Month 1 to Month 3, Month 6, and Month 9.
Change in Weight
To show the change (decrease) in weight over 9 months.
Measured: Baseline to 3 months, 6 months, and 9 months.
Change in Dietary Intake (Sodium)
To show the change (decrease) in dietary intake (sodium) over 9 months.
Measured: Month 1 to Month 3, Month 6, and Month 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start28 Jan 2019
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will test the effects of ITEC added to CDSMP on two study aims: 1) BP control, and 2) adherence to antihypertensive medication and lifestyle modifications. After baseline data collection, participants complete a 6-week CDSMP course and then are randomly assigned to either the treatment or control arm. All participants will continue to receive usual care for HTN. The treatment group will receive ITEC and wireless tools to track activity, BP, weight, food intake, and self-report medication-taking after an orientation to Fitbit Plus (a cloud-based collaborative care platform designed to store and track data). All tools will be synced to the participants' smartphone. The treatment arm will receive weekly ITEC for 3 months, biweekly ITEC for 3 months, and then no ITEC for 3 months. The control arm will receive usual care only with monthly BP measured manually for 3 months and then receive the same wireless tools with monitoring to track comparative data with the treatment arm.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Willie Abel, University of North Carolina, Charlotte
- Investigators
- Willie M Abel, PhD, Principal investigator, The University of North Carolina at CharlotteMark J DeHaven, PhD, Study director, The University of North Carolina at Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577990
- Sponsor's protocol ID
- 17-0549
- Other IDs
- 1K01HL140288
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2018
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abel WM, Spikes T, Greer DB. A Qualitative Study: Hypertension Stigma Among Black Women: Erratum. J Cardiovasc Nurs. 2025 May-Jun 01;40(3):279. doi: 10.1097/JCN.0000000000001213. No abstract available.
PubMed 40198262Abel WM, DeHaven MJ. An interactive technology enhanced coaching intervention for Black women with hypertension: Randomized controlled trial study protocol. Res Nurs Health. 2021 Feb;44(1):24-36. doi: 10.1002/nur.22090. Epub 2020 Dec 15.
PubMed 33319386
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive Technology Enhanced Coaching Intervention for Black Women With Hypertension
- ClinicalTrials.gov ID
- NCT03577990
- Acronym / sponsor ID
- 17-0549
- Conditions
- Uncontrolled Hypertension
- Keywords
- hypertension, Black women, self-management, coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.
Detailed description
This study includes a sample of community dwelling Black women with uncontrolled HTN. All participants meeting study eligibility requirements will receive the Chronic Disease Self-Management Program (CDSMP) workshop for 6 weeks. Participants from this pool will be randomized to the treatment and control arm. All study participants will continue to receive usual care for their HTN.
The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm will receive electronic monitoring (of participants' BP, weight, physical activity, food diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC) while the control arm will receive usual care with manual BP measurements monthly. At Step 2 for three months, the treatment arm will receive electronic monitoring with ITEC biweekly, and the control arm will receive electronic monitoring only. At Step 3 for three months, both the treatment arm and the control arm will receive electronic monitoring only.
Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic measurements, anthropometric measurements, and data collection tools) at baseline, 3 months, 6 months, and at 9 months post CDSMP. A hierarchical, mixed-effects repeated measures design will be used to analyze the data.
The project is a two-arm randomized controlled trial with specific aims to determine whether the effects of CDSMP combined with ITEC will maintain BP control, attain medication adherence, and achieve lifestyle modifications (physical activity, diet, and weight management) compared to the CDSMP alone. We will test the hypothesis that:
- More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in CDSMP alone.
- More participants in the CDSMP/ITEC arm will have higher levels of adherence to antihypertensive medication(s) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
- More participants in the CDSMP/ITEC arm, will have higher levels of adherence to lifestyle modifications (physical activity, diet, and weight management) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone.
Information from this study may be used to enhance self-care management, control blood pressure, and increase the quality of life for Black women who are burdened with the adverse effects of HTN and its high disability and mortality rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will test the effects of ITEC added to CDSMP on two study aims: 1) BP control, and 2) adherence to antihypertensive medication and lifestyle modifications. After baseline data collection, participants complete a 6-week CDSMP course and then are randomly assigned to either the treatment or control arm. All participants will continue to receive usual care for HTN. The treatment group will receive ITEC and wireless tools to track activity, BP, weight, food intake, and self-report medication-taking after an orientation to Fitbit Plus (a cloud-based collaborative care platform designed to store and track data). All tools will be synced to the participants' smartphone. The treatment arm will receive weekly ITEC for 3 months, biweekly ITEC for 3 months, and then no ITEC for 3 months. The control arm will receive usual care only with monthly BP measured manually for 3 months and then receive the same wireless tools with monitoring to track comparative data with the treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Experimental | Behavioral: Interactive Technology Enhanced Coaching (ITEC)Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability. |
| Interactive Technology-No Coaching (IT) | Active comparator | Behavioral: Interactive Technology-No Coaching (IT)Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified as Black or African American;
- 18-70 years of age
- English speaking
- Has to live in the study community, Charlotte or surrounding area
- Systolic BP greater than or equal to 130 and/or diastolic BP greater than or equal to 80 at screening
Key exclusion criteria (7 listed)
- Self-report of mental illness that interferes with daily functioning
- Unable to be physically active
- Current pregnancy
- Plans to move from the study area during the project
- Systolic BP greater than or equal to 160 and/or diastolic BP greater than or equal to 100
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 |
|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC)As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability. | Behavioural | Interactive Technology Enhanced Coaching (ITEC) |
| Interactive Technology-No Coaching (IT)After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily. | Behavioural | Interactive Technology-No Coaching (IT) |
Primary outcome
Change in Systolic and Diastolic Blood Pressure (BP)
Time frame: Baseline to 3 months, 6 months, and 9 months.
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
5 secondary outcomes
Medication Adherence by Proportion of Days Covered
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Physical Activity (Change in Daily Steps)
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Change in Dietary Intake (Calories)
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Change in Weight
Time frame: Baseline to 3 months, 6 months, and 9 months.
Change in Dietary Intake (Sodium)
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40198262Abel WM, Spikes T, Greer DB. A Qualitative Study: Hypertension Stigma Among Black Women: Erratum. J Cardiovasc Nurs. 2025 May-Jun 01;40(3):279. doi: 10.1097/JCN.0000000000001213. No abstract available.
- Derived from this study: PubMed 33319386Abel WM, DeHaven MJ. An interactive technology enhanced coaching intervention for Black women with hypertension: Randomized controlled trial study protocol. Res Nurs Health. 2021 Feb;44(1):24-36. doi: 10.1002/nur.22090. Epub 2020 Dec 15.
- 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.
Willie M Abel, PhD principal investigator
The University of North Carolina at Charlotte
Mark J DeHaven, PhD study director
The University of North Carolina at Charlotte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Technology Enhanced Coaching (ITEC) and Interactive Technology-No Coaching (IT) in people with Uncontrolled Hypertension, run by University of North Carolina, Charlotte at 1 site 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 8 inclusion and 7 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Systolic and Diastolic Blood Pressure (BP) (time frame: Baseline to 3 months, 6 months, and 9 months.). 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 NCT03577990, which also lists 2 linked publications.
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 17 May 2023.