Kamakshi Lakshminarayan1, Sarah Westberg2, Carin Northuis3, Candace C Fuller4, Farah Ikramuddin5, Mustapha Ezzeddine6, Julie Scherber7, Stuart Speedie8. 1. Division of Epidemiology & Community Health, University of Minnesota, School of Public Health, United States. Electronic address: laksh004@umn.edu. 2. Department of Pharmaceutical Care and Health Systems, University of Minnesota, College of Pharmacy, United States. 3. Division of Epidemiology & Community Health, University of Minnesota, School of Public Health, United States. 4. Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, United States. 5. Department of Rehabilitation Medicine, University of Minnesota, United States. 6. Department of Neurology, University of Minnesota, United States. 7. Department of Medicine, University of Minnesota, United States. 8. Institute for Health Informatics, University of Minnesota, United States.
Abstract
PURPOSE:Hypertension (HTN) is significantly under-treated in stroke survivors. We examined usability and efficacy of a mHealth -based care model for improving post-stroke HTN control (Funding: AHRQ R21HS021794). METHODS: We used a RCT design. Planned study duration was 90 days. Intervention arm (IA) participants measured their BP daily using a smart phone and wireless BP monitor. This was transmitted automatically to the study database. Investigators (Physician + PharmD) made bi-weekly medication adjustments to achieve the BP goal. Control arm (CA) participants received a digital BP monitor and usual care. We examined Usability (measured with Marshfield System Usability Survey) and HTN control efficacy using an ITT (intent-to-treat) and as-treated (AT) analyses. RESULTS:Fifty participants (IA = 28; CA = 22) completed the study. The Marshfield survey question, "I thought the system was easy to use" mean score was 4.6, (5 = strongly agree). Mean SBP declined significantly between enrollment and study completion in the IA. In ITT, IA SBP declined 9.88 mm, p = 0.005. In AT, IA SBP declined 10.81 mm, p = 0.0036. CA SBP decline was 5-6 mm Hg (not significant). In the ITT, baseline HTN control (SBP < 140 mm Hg) was 50% in IA and CA. At study completion, HTN was controlled in 82% (23/28) of IA and 64% (14/22) of CA (p = 0.14). In the AT, HTN was controlled in 89% (23/26) of IA and 58% (14/24) of CA, (p = 0.015). CONCLUSION: A mHealth-based HTN care model had excellent usability and provided better HTN control than usual care in stroke survivors. CLINICAL TRIAL: gov: NCT01875094.
RCT Entities:
PURPOSE:Hypertension (HTN) is significantly under-treated in stroke survivors. We examined usability and efficacy of a mHealth -based care model for improving post-stroke HTN control (Funding: AHRQ R21HS021794). METHODS: We used a RCT design. Planned study duration was 90 days. Intervention arm (IA) participants measured their BP daily using a smart phone and wireless BP monitor. This was transmitted automatically to the study database. Investigators (Physician + PharmD) made bi-weekly medication adjustments to achieve the BP goal. Control arm (CA) participants received a digital BP monitor and usual care. We examined Usability (measured with Marshfield System Usability Survey) and HTN control efficacy using an ITT (intent-to-treat) and as-treated (AT) analyses. RESULTS: Fifty participants (IA = 28; CA = 22) completed the study. The Marshfield survey question, "I thought the system was easy to use" mean score was 4.6, (5 = strongly agree). Mean SBP declined significantly between enrollment and study completion in the IA. In ITT, IA SBP declined 9.88 mm, p = 0.005. In AT, IA SBP declined 10.81 mm, p = 0.0036. CA SBP decline was 5-6 mm Hg (not significant). In the ITT, baseline HTN control (SBP < 140 mm Hg) was 50% in IA and CA. At study completion, HTN was controlled in 82% (23/28) of IA and 64% (14/22) of CA (p = 0.14). In the AT, HTN was controlled in 89% (23/26) of IA and 58% (14/24) of CA, (p = 0.015). CONCLUSION: A mHealth-based HTN care model had excellent usability and provided better HTN control than usual care in stroke survivors. CLINICAL TRIAL: gov: NCT01875094.
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