Technology-based Intervention and Positive Psychological Training for Blood Pressure Control in African Americans

NCT03722667 | Completed DMC

• 1 other identifier: 5P30NR015326-05
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.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.
2. 2.Determine whether there are differences in self-management behaviors (medication adherence, diet, exercise, self-monitoring BP) between the two groups.
3. 3.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.
4. 4.Determine if social support, demographics (age, gender, education), discrimination, and technology utilization moderate self-management behaviors, BP, HRQoL, and psychological health.
5. 5.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.

Conditions

Hypertension; Self-management; Technology

Outcome Measures

Primary Outcomes (5)

• Change in systolic and diastolic blood pressure

  Measure of participants' in clinic blood pressure (average of three blood pressure readings)

  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.

  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.

  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.

  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.

  Baseline to 8 weeks and 12 weeks

Study Arms (2)

Technology-Based Component

PLACEBO COMPARATOR

A Technology-based interventions comprised of three technolgy components accessible via smartphone to support self-managing hypertension.

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.

Behavioral: TechSupport

Interventions

Technology-based Component BEHAVIORAL

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.

Technology-Based Component

TechSupport BEHAVIORAL

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.

TechSupport

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as African American
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44143, United States

Location

Related Publications (2)

• 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.

  PMID: 35302958 DERIVED

• Still 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.

  PMID: 33262580 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carolyn H Still, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Frances Payne Bolton School of Nursing

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 29, 2018
• Study Start: October 25, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)