HypertensionTechSupportNCT03722667
Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans
A study testing Technology-based Component and TechSupport in people with Hypertension and Self-management, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Self-management, Technology
- What is being tested?
- Technology-based Component and TechSupport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 31 Jul 2019
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as African American
- 25 years and older
- diagnosed with hypertension defined, as BP ≥ 130/80 mmHg
- Taking at least one antihypertensive medication(s)
- own an android smartphone
- able to read and understand English
Who cannot join
- are unable to give informed consent or judged to have impaired cognitive ability or severe memory deficits
- currently practicing positive psychological training
- have a history of medical conditions or procedures that is contraindicated for fMRI scanning (cardiac pacemaker, sternal wires, or metal implants)
- have a history of claustrophobia requiring anxiolytics or sedation
- pregnant at time of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44143
About this study
Official title: The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
The purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans.
The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to:
- Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm.
- Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
- Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors.
- Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
- Explore differences in neural processing (diffusion tensor imaging [DTI]/ task positive network [TPN] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.
Read the detailed description
The investigators will conduct a two-arm randomized clinical trial to compare the effects of an Technology-Based Component Only arm and TechSuPPorT on self-management behaviors, BP control, and HRQoL outcomeson cognitive task switching between the DMN and TPN neural networks using Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). Both groups will be exposed to the three Technology-based components: (a) six weekly web-based modules focused on improving African Americans' knowledge and skills of hypertension management; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe, a smartphone app; and (c) self-monitor BP with study provided BP monitor. Participants in the TechSuPPorT arm will receive the three Technology-based components plus positive psychological training, a structured online training and skill building techniques to promote optimism, resilience, well-being, and self-confidence.
- Conditions
- Hypertension, Self-management, Technology
- Being tested
- Technology-based Component, TechSupport
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based ComponentBehavioural
This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.
TechSupportBehavioural
The TechSupport intervention is the combination of both an behavioral and emotional intervention.
Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.
Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence.
| Study group | Role | What they receive |
|---|---|---|
| Technology-Based Component | Placebo comparator | A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension. Receives: Behavioral: Technology-based Component |
| TechSupport | Experimental | A Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension. Receives: Behavioral: TechSupport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Measure of participants' in clinic blood pressure (average of three blood pressure readings)
Measured: Baseline to 8 weeks and 12 weeks
PROMIS Global Health-10 [health-related quality of life]
Change in total summed score on PROMIS Global Health-10. Higher scores indicate greater health-related quality of life. Range is 4-20.
Measured: Baseline to 8 weeks and 12 weeks
PROMIS Short Form, Positive Affect -15a [positive affect and well-being]
Change in total summed score on PROMIS Short Form, Positive Affect 15a. Higher scores indicate greater positive affect and well being. Range is 15-45.
Measured: Baseline to 8 weeks and 12 weeks
PROMIS- 29, Depression Subscale 4a [depressive symptoms]
Change in total summed PROMIS-29, Depression Subscale 4a. Higher scores indicate greater depressive symptoms. Range is 4 to 20.
Measured: Baseline to 8 weeks and 12 weeks
PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]
Change in total summed PROMIS-29, Anxiety subscale. Higher scores indicate greater anxiety. Range is 4-20.
Measured: Baseline to 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start25 Oct 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators hypothesize that African Americans' hypertension self-management behaviors are influenced by the ability of the individual to task differentiate between the DMN and TPN neural processing. Furthermore, such behaviors will lead to improved BP control and HRQoL. Using a two-arm RCT pilot study, investigators will compare the effects of TechSuPPorT and the Technology-based component arm on BP, HRQoL, and psychological health (affective well-being, depressive symptoms, anxiety) and cognitive task differentiation of the DMN and TPN neural networks. Data will be collected at three points: baseline, 8 weeks and 12 weeks. Brain scans (fMRIs) will be captured at baseline and following the intervention at 8 weeks.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Carolyn Still, Case Western Reserve University
- Investigators
- Carolyn H Still, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722667
- Sponsor's protocol ID
- 5P30NR015326-05
- Acronym
- TechSupport
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Still CH, Jack AI, Wright KD, Sattar A, Moore SM. Neural Processing of Health Information and Hypertension Self-Management in African Americans. Nurs Res. 2022 Jul-Aug 01;71(4):303-312. doi: 10.1097/NNR.0000000000000592. Epub 2022 Mar 18.
PubMed 35302958Still CH, Margevicius S, Harwell C, Huang MC, Martin L, Dang PB, Wright Jnr JT. A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study. Patient Prefer Adherence. 2020 Nov 23;14:2301-2313. doi: 10.2147/PPA.S283086. eCollection 2020.
PubMed 33262580
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Technology-based Intervention and Positive Psychological Training on Cognitive Processing and Blood Pressure Control in African Americans
- ClinicalTrials.gov ID
- NCT03722667
- Acronym / sponsor ID
- TechSupport / 5P30NR015326-05
- Conditions
- Hypertension, Self-management, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 29 Oct 2018 (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 purpose of this pilot study is to evaluate the effects of a theoretically-derived technology-based intervention (called TechSuPPorT) and its associated neurological mechanisms for hypertension self-management in African Americans.
The investigators will compare two intervention arms in this study, the Technology-Based Component Only arm (comparison group) and the TechSuPPorT arm (intervention group) in 20 African Americans with uncontrolled hypertension. We aim to:
- Determine whether there are differences in blood pressure (BP), health-related quality of life (HRQoL), and psychological health (affective well-being, depressive cognitions, anxiety) betweenTechSuPPorT and the Technology-based Component only arm.
- Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
- Examine whether self-efficacy, decision-making, motivation, patient activation, and perceived stress, and positive emotions mediate the relationship between the interventions and self-management behaviors.
- Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
- Explore differences in neural processing (diffusion tensor imaging [DTI]/ task positive network [TPN] task-differentiation), and stress response (cortisol and inflammation panel) between the two groups.
Detailed description
The investigators will conduct a two-arm randomized clinical trial to compare the effects of an Technology-Based Component Only arm and TechSuPPorT on self-management behaviors, BP control, and HRQoL outcomeson cognitive task switching between the DMN and TPN neural networks using Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). Both groups will be exposed to the three Technology-based components: (a) six weekly web-based modules focused on improving African Americans' knowledge and skills of hypertension management; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe, a smartphone app; and (c) self-monitor BP with study provided BP monitor. Participants in the TechSuPPorT arm will receive the three Technology-based components plus positive psychological training, a structured online training and skill building techniques to promote optimism, resilience, well-being, and self-confidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators hypothesize that African Americans' hypertension self-management behaviors are influenced by the ability of the individual to task differentiate between the DMN and TPN neural processing. Furthermore, such behaviors will lead to improved BP control and HRQoL. Using a two-arm RCT pilot study, investigators will compare the effects of TechSuPPorT and the Technology-based component arm on BP, HRQoL, and psychological health (affective well-being, depressive symptoms, anxiety) and cognitive task differentiation of the DMN and TPN neural networks. Data will be collected at three points: baseline, 8 weeks and 12 weeks. Brain scans (fMRIs) will be captured at baseline and following the intervention at 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Technology-Based Component | Placebo comparator | Behavioral: Technology-based ComponentA Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension. |
| TechSupport | Experimental | Behavioral: TechSupportA Technology-based interventions comprised of three technolgy components plus positive psychological training accessible by smartphone to support self-managing hypertension. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- self-identify as African American
- 25 years and older
- diagnosed with hypertension defined, as BP ≥ 130/80 mmHg
- Taking at least one antihypertensive medication(s)
- own an android smartphone
Key exclusion criteria (5 listed)
- are unable to give informed consent or judged to have impaired cognitive ability or severe memory deficits
- currently practicing positive psychological training
- have a history of medical conditions or procedures that is contraindicated for fMRI scanning (cardiac pacemaker, sternal wires, or metal implants)
- have a history of claustrophobia requiring anxiolytics or sedation
- pregnant at time of enrollment
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 |
|---|---|---|
| Technology-based ComponentThis intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension. | Behavioural | Technology-Based Component |
| TechSupportThe TechSupport intervention is the combination of both an behavioral and emotional intervention. Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension. Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence. | Behavioural | TechSupport |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: Baseline to 8 weeks and 12 weeks
Measure of participants' in clinic blood pressure (average of three blood pressure readings)
PROMIS Global Health-10 [health-related quality of life]
Time frame: Baseline to 8 weeks and 12 weeks
Change in total summed score on PROMIS Global Health-10. Higher scores indicate greater health-related quality of life. Range is 4-20.
PROMIS Short Form, Positive Affect -15a [positive affect and well-being]
Time frame: Baseline to 8 weeks and 12 weeks
Change in total summed score on PROMIS Short Form, Positive Affect 15a. Higher scores indicate greater positive affect and well being. Range is 15-45.
PROMIS- 29, Depression Subscale 4a [depressive symptoms]
Time frame: Baseline to 8 weeks and 12 weeks
Change in total summed PROMIS-29, Depression Subscale 4a. Higher scores indicate greater depressive symptoms. Range is 4 to 20.
PROMIS- 29, Anxiety Subscale 4a [anxiety symptoms]
Time frame: Baseline to 8 weeks and 12 weeks
Change in total summed PROMIS-29, Anxiety subscale. Higher scores indicate greater anxiety. Range is 4-20.
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 16 Sep 2020.
- Derived from this study: PubMed 35302958Still CH, Jack AI, Wright KD, Sattar A, Moore SM. Neural Processing of Health Information and Hypertension Self-Management in African Americans. Nurs Res. 2022 Jul-Aug 01;71(4):303-312. doi: 10.1097/NNR.0000000000000592. Epub 2022 Mar 18.
- Derived from this study: PubMed 33262580Still CH, Margevicius S, Harwell C, Huang MC, Martin L, Dang PB, Wright Jnr JT. A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study. Patient Prefer Adherence. 2020 Nov 23;14:2301-2313. doi: 10.2147/PPA.S283086. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Carolyn H Still, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based Component and TechSupport in people with Hypertension and Self-management, run by Case Western Reserve University 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 6 inclusion and 5 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 16 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Change in systolic and diastolic blood pressure (time frame: Baseline to 8 weeks and 12 weeks). The study lists 5 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 NCT03722667, 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 16 Sep 2020.