Mobile Health Management of Hypertension

Hypertension Clinical Trial

Official title:

Mobile Health for Enhanced Hypertension Self-Management in Underserved Urban Residents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05856955
• Other study ID #: STUDY23040080
• Secondary ID: K23HL165110-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: University of Pittsburgh
• Contact: Amber Johnson, MD
• Phone: 4126476000
• Email: johnsonae2[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will pilot test a hypertension self-management intervention for feasibility and acceptability. The investigators will enroll adults (age ≥18) with uncontrolled hypertension, identified from the electronic health record. In this feasibility trial, the research aim is to explore trial design, participant acceptability of the intervention and outcome measures, and to generate data to inform the design of a future randomized controlled trial.

Description:

The investigators will pilot test a hypertension self-management intervention for feasibility and acceptability. This is a pilot study to gain experience in enrolling and retaining patients from the identified population and collecting outcome variables. Study cohort: The investigators will enroll adults (age ≥18) with uncontrolled hypertension, identified from the electronic health record problem list and an average systolic blood pressure (BP) of 150-199 or diastolic of 95-119 mmHg at 2 ambulatory visits, 1 of which is within 6 months of study entry. These BP criteria ensure enrollment of individuals who warrant improved BP control. In this feasibility trial, the research aim is to explore trial design, participant acceptability of the intervention and outcome measures, and to generate data to inform the design of a future RCT. We will employ a validated approach to determine feasibility (e.g., acceptability, satisfaction, and practicality).

All secondary measures will be collected at baseline, 30 days, and end of intervention (90 days). These outcomes are pilot measures that will be used in a subsequent full-scale efficacy trial of the intervention.

Study protocol. Duration = 90 days. Allocation will use a randomly permuted block design. The investigators will provide smartphones and cellular subscriptions to all participants, as in their prior studies of cardiovascular disease mobile health interventions. This obviates the need for smartphone ownership or internet access. Participants randomized to the intervention group will receive the smartphone with the intervention program preloaded in addition to a BP monitor. The active comparison group will receive a smartphone with a basic health information application preloaded and a BP monitor. After recruitment, participants will receive a confirmatory interview, informed consent, and baseline device training via telephone, delivered by an experienced research assistant. Participants will be encouraged to complete 1 morning BP reading daily, irrespective of study arm, however, only the intervention group will receive reminders from the mHealth coaching intervention to check BP daily. BP readings are automatically uploaded via Bluetooth to a centralized, secure platform to be accessible to the study PI. Participants will receive $20 for the baseline telephone visit and $40 at study completion. As in the groups' prior RCTs, the final payment requires return of the smartphone.

Sample Size Justification and Recruitment. Investigators will focus on feasibility outcomes among 40 patients, following examples in the literature and guidelines for feasibility studies, which recommend against estimating preliminary efficacy or standard errors using pilot data. Nevertheless, with 40 participants, the investigators will have the ability to calculate point estimates and 95% confidence intervals with a margin of error of 0.22. The cohort of 40 will be reasonably recruited in the allotted timeframe. Culturally sensitive recruitment strategies will be employed to ensure participant diversity. In addition, participants will be recruited from outpatient clinics via HIPAA-compliant, IRB approved protocols. The investigators will deploy IRB-approved virtual recruitment strategies previously developed by the study's PI with study brochure and opt-out postcard; electronic health record screening for eligibility; telephone-based confirmatory interview, and informed consent.

Statistical Analysis. Descriptive data, such as means, standard deviations, and sample proportions, will be reported for all participants and by study arm. Data with non-normal distributions will be transformed, as needed. The primary focus will be on feasibility and acceptability as defined above. Primary outcomes will be assessed with point estimates and 95% CIs. Any between-arm differences will be examined using χ2 tests or 2-sided Fisher's exact test for categorical variables, and 2-tailed t tests for continuous variables. Continuous secondary outcomes (locus of control, resilience, BP) will be analyzed using ANCOVA comparing 90-day outcomes between arms after adjusting for baseline BP. The proportion of participants who are normotensive will be analyzed by logistic regression as a function of study arm.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prescribed use of 1 or more antihypertensive medications

• English-speaking

• Residence in a disadvantaged neighborhood

Exclusion Criteria:

• History of malignant HTN

• Inability to comprehend the study protocol

• Institutionalized status

• Significant sensory or neurocognitive deficit

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• mHealth Coaching Intervention
The intervention uses a mHealth virtual tool that facilitates human-device interaction and is delivered by smartphone application. The program has coaching and education components that lead to chronic disease behavior change. It has been previously validated to improve self-management, medication adherence, and quality of life in individuals with CVD. The participant engages by selecting responses on the touch screen. In this manner, participants converse with the coach, develop a therapeutic alliance, and record responses. The investigators will institute behavior change methodology to enhance intervention efficacy.
• Enhanced Usual Care
Smart phone without health coach. A basic health application is installed on the smart phone provided to the participant.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (18)

Band R, Bradbury K, Morton K, May C, Michie S, Mair FS, Murray E, McManus RJ, Little P, Yardley L. Intervention planning for a digital intervention for self-management of hypertension: a theory-, evidence- and person-based approach. Implement Sci. 2017 Feb 23;12(1):25. doi: 10.1186/s13012-017-0553-4. — View Citation

Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002. — View Citation

Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27. — View Citation

Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. — View Citation

Elgazzar R, Nolan TS, Joseph JJ, Aboagye-Mensah EB, Azap RA, Gray DM 2nd. Community-engaged and community-based participatory research to promote American Heart Association Life's Simple 7 among African American adults: A systematic review. PLoS One. 2020 Sep 1;15(9):e0238374. doi: 10.1371/journal.pone.0238374. eCollection 2020. — View Citation

Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484. — View Citation

Lakshminarayan K, Westberg S, Northuis C, Fuller CC, Ikramuddin F, Ezzeddine M, Scherber J, Speedie S. A mHealth-based care model for improving hypertension control in stroke survivors: Pilot RCT. Contemp Clin Trials. 2018 Jul;70:24-34. doi: 10.1016/j.cct.2018.05.005. Epub 2018 May 12. — View Citation

Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28. — View Citation

Magnani JW, Ferry D, Swabe G, Martin D, Chen X, Brooks MM, Kimani E, Paasche-Orlow MK, Olafsson S, Bickmore T, El Khoudary SR. Design and rationale of the mobile health intervention for rural atrial fibrillation. Am Heart J. 2022 Oct;252:16-25. doi: 10.1016/j.ahj.2022.05.023. Epub 2022 Jun 9. — View Citation

Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x. — View Citation

Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012 Mar;65(3):301-8. doi: 10.1016/j.jclinepi.2011.07.011. Epub 2011 Dec 9. — View Citation

Taub HA, Baker MT. The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. Exp Aging Res. 1983 Fall;9(3):135-8. doi: 10.1080/03610738308258441. — View Citation

Turner-McGrievy GM, Wilson MJ, Bailey S, Bernhart JA, Wilcox S, Frongillo EA, Murphy EA, Hutto B. Effective recruitment strategies for African-American men and women: the Nutritious Eating with Soul study. Health Educ Res. 2021 Apr 12;36(2):206-211. doi: 10.1093/her/cyab003. — View Citation

Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. No abstract available. — View Citation

van den Born BH, Lip GYH, Brguljan-Hitij J, Cremer A, Segura J, Morales E, Mahfoud F, Amraoui F, Persu A, Kahan T, Agabiti Rosei E, de Simone G, Gosse P, Williams B. ESC Council on hypertension position document on the management of hypertensive emergencies. Eur Heart J Cardiovasc Pharmacother. 2019 Jan 1;5(1):37-46. doi: 10.1093/ehjcvp/pvy032. Erratum In: Eur Heart J Cardiovasc Pharmacother. 2019 Jan 1;5(1):46. — View Citation

Viechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6. — View Citation

Voils CI, Maciejewski ML, Hoyle RH, Reeve BB, Gallagher P, Bryson CL, Yancy WS Jr. Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care. 2012 Dec;50(12):1013-9. doi: 10.1097/MLR.0b013e318269e121. — View Citation

Wallston KA. The validity of the multidimensional health locus of control scales. J Health Psychol. 2005 Sep;10(5):623-31. doi: 10.1177/1359105305055304. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant acceptance and adherence to program	80% of participants receiving intervention will have strong engagement, defined by >60 logins	90 days
Primary	Participant satisfaction and usability	80% of participants receiving intervention will indicate talking with the coach was easy on a 7-point Likert scale (1=Easy; 7=Difficult)	90 days post index discharge
Primary	Practicality of participant self-monitoring behavior	80% of participants receiving intervention will have recorded their BP >60 times	90 days
Secondary	Locus of control	a measure of beliefs that one's health is determined by factors either intrinsic or extrinsic to one's self. Uses the 24-item Multidimensional Health Locus of Control.	90 days
Secondary	Resilience	Resilience is an important measure given our asset-based approach signifying that some communities have good health outcomes despite having high predicted risk. Uses Connor-Davidson Scale.	90 days
Secondary	Medication Adherence	3-item self-report adherence measure. Uses Voil's adherence scale.	90 days
Secondary	Blood pressure change	Change in BP results from baseline to day 90. Measured in mmHg.	90 days
Secondary	Blood pressure control	Proportion of participants with normal BP (i.e., <135/<85 mmHg) at day 90	90 days