Technology-augmented Self-monitoring Model Among Patients With Type 2 Diabetes and Hypertension

October 26, 2017 updated by: Dr. Calvin Or, The University of Hong Kong

Evaluating a Technology-augmented Self-monitoring Model for Glycemic and Blood Pressure Control and Medication Adherence in Type 2 Diabetes and Hypertension Patients: a Randomized Controlled Trial

Objective: To develop and evaluate a technology-augmented self-monitoring model using a randomized controlled trial to demonstrate whether patients with co-morbid type 2 diabetes mellitus and hypertension can improve their glycemic and blood pressure control, adherence to medication regimens, and other relevant outcomes by using a tablet-based consumer health information technology (CHIT) to support the self-monitoring and self-management of their chronic conditions.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subject recruitment: The person-in-charge/managers of the departments of the hospitals/the health service centers will go through the in-house medical documents to identify adults with a diagnosis of type 2 diabetes and hypertension and invite them to attend an information session, in which the project's lead PI (Dr. Calvin Or) and research assistants will introduce the study; determine their eligibility based on their self-reported demographic data, health information, and/or medical records; and collect their contact information. Later, the research assistant will telephone the eligible patients to schedule a first visit to their homes for enrollment.

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.

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • 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 abnormal vision and physical impairments
  • with any unstable or life-threatening illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in HbA1c
Time Frame: from baseline to 12 and 24 weeks
from baseline to 12 and 24 weeks
changes in systolic and diastolic blood pressure
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
medication adherence
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks
adherence to diabetes self-care activities
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks
adherence to hypertension self-care activities
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks
changes in answering diabetes knowledge questions
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks
changes in answering hypertension knowledge questions
Time Frame: from baseline to 8, 16, and 24 weeks
from baseline to 8, 16, and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Calvin Or, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 11, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMRF12133231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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