Technology-augmented Self-monitoring Model Among Patients With Type 2 Diabetes and Hypertension
NCT ID: NCT02799953
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2016-03-31
2017-04-30
Brief Summary
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Design: A two-group, randomized controlled trial with follow-up assessments 8, 12, 16, and 24 weeks after the baseline evaluation.
Setting: Patients' homes.
Participants: Two hundred and ninety-six adult patients with type 2 diabetes mellitus and hypertension who receive their health care from a local community health service network or a major hospital will be recruited.
Interventions: Participants in the technology-augmented self-monitoring model (intervention group) will use a tablet-based, interactive touch screen self-monitoring system to monitor and manage their chronic conditions. The system is designed to augment patients' abilities to assess, record, and review their health signs while providing text-, audio-, and video-based resources supporting disease self-care. The participants in the usual-care group will perform conventional self-monitoring.
Outcome measures: The primary outcomes will be glycemic control measured by changes in HbA1c,blood pressure control assessed by changes in systolic and diastolic blood pressure, and medication compliance. The secondary outcomes will be adherence to diabetes and hypertension self-care activities and knowledge of diabetes and hypertension.
Implication: This study will improve our understanding of the clinical value of CHITs in chronic disease self-monitoring and self-management.
Detailed Description
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Intervention: The participants randomized to the intervention group will be given a tablet-based, interactive touch-screen self-monitoring system free of charge to perform disease self-monitoring in their homes. The objectives of the system are to empower patients' ability to self-monitor and improve their self-care adherence and medication compliance by enabling access to various e-support, information, resources, and self-monitoring tools in a timely manner. It runs on a 10-inch touch-screen tablet computer that is programmed to connect to a 2-in-1 blood pressure and glucose monitor. Measurement modules are available for assessing and recording blood pressure, pulse, and blood glucose level. The assessment records are fully automated and can be retrieved and reviewed in structured tables and charts. Patients can determine whether assessment values that deviate from the critical levels may need attention based on the "normal value ranges" indicated by the system. The system also has a module that provides both text- and video-based learning resources related to the causes and prevention of type 2 diabetes and hypertension, self-care, salt and sodium intake, diet, action plan (e.g., appropriate actions in response to symptoms), exercise, and stress management. The care information and video capability allow patients to easily learn how to self-monitor and self-manage. In addition, the system has a reminder function that can be programmed to emit audible reminders at predetermined times alerting patients to take their prescribed medications. A secured web portal (http://selfcare.imse.hku.hk/) is available for authorized, non-patient users such as caregivers and families to remotely review and monitor the assessment values of key patient health signs using their own mobile devices or computers.
Randomization: Participants will be stratified into four groups based on the HbA1c and systolic blood pressure measurements: (i) HbA1c ≤ 8% and systolic BP ≤ 159 mm Hg, (ii) HbA1c ≤ 8% and systolic BP ≥ 160 mm Hg, (iii) HbA1c \> 8% and systolic BP ≤ 159 mm Hg, and (iv) HbA1c \> 8% and systolic BP ≥ 160 mm Hg. These cut-offs for grouping were set based on previous studies (2, 3) and clinical judgement. Within each stratum, the patients will be block-randomized into the study groups using randomly permuted blocks and sequentially numbered, opaque, sealed envelopes. The randomization and allocation process will be based on the practical guide for permuted blocks randomization in a stratified trial, as described in Doig and Simpson (4), and handled centrally by a researcher in response to a telephone call.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Technology-based self-management model
Participants randomized to the intervention group will be given a tablet-based, interactive touch-screen self-monitoring system free of charge to perform disease self-monitoring in their homes.
Technology-based self-management model
Participants in the technology-augmented self-monitoring model (intervention group) will use a tablet-based, interactive touch screen self-monitoring system to monitor and manage their chronic conditions. The system is designed to augment patients' abilities to assess, record, and review their health signs while providing text-, audio-, and video-based resources supporting disease self-care.
Conventional self-management
Participants randomized to the usual care group will not be provided access to tablet computers but a 2-in-1 blood pressure and blood glucose monitor and a paper-based log book to perform conventional self-monitoring.
No interventions assigned to this group
Interventions
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Technology-based self-management model
Participants in the technology-augmented self-monitoring model (intervention group) will use a tablet-based, interactive touch screen self-monitoring system to monitor and manage their chronic conditions. The system is designed to augment patients' abilities to assess, record, and review their health signs while providing text-, audio-, and video-based resources supporting disease self-care.
Eligibility Criteria
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Inclusion Criteria
* with a physician-confirmed diagnosis of type 2 diabetes and hypertension of at least 1 month's duration
* normal (or corrected-to-normal) vision
* no cognitive or physical impairment
* ability to perform disease self-monitoring and self-management
* a willingness to use the tablet self-monitoring system
* the ability to understand written and spoken Chinese
Exclusion Criteria
* with any unstable or life-threatening illness
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Dr. Calvin Or
Assistant Professor
Principal Investigators
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Calvin Or, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong, China
Countries
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References
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Or C, Tao D. Usability study of a computer-based self-management system for older adults with chronic diseases. JMIR Res Protoc. 2012 Nov 8;1(2):e13. doi: 10.2196/resprot.2184.
Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. doi: 10.1001/jama.299.24.2857.
McMahon GT, Gomes HE, Hickson Hohne S, Hu TM, Levine BA, Conlin PR. Web-based care management in patients with poorly controlled diabetes. Diabetes Care. 2005 Jul;28(7):1624-9. doi: 10.2337/diacare.28.7.1624.
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
Or CK, Liu K, So MKP, Cheung B, Yam LYC, Tiwari A, Lau YFE, Lau T, Hui PSG, Cheng HC, Tan J, Cheung MT. Improving Self-Care in Patients With Coexisting Type 2 Diabetes and Hypertension by Technological Surrogate Nursing: Randomized Controlled Trial. J Med Internet Res. 2020 Mar 27;22(3):e16769. doi: 10.2196/16769.
Other Identifiers
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HMRF12133231
Identifier Type: -
Identifier Source: org_study_id