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

NCT02799953 | Completed

• 1 other identifier: HMRF12133231
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Hypertension

Keywords

diabetes mellitus and hypertension; consumer health information technology; self-monitoring; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• changes in HbA1c

  from baseline to 12 and 24 weeks

• changes in systolic and diastolic blood pressure

  from baseline to 8, 16, and 24 weeks

Secondary Outcomes (5)

• medication adherence

  from baseline to 8, 16, and 24 weeks

• adherence to diabetes self-care activities

  from baseline to 8, 16, and 24 weeks

• adherence to hypertension self-care activities

  from baseline to 8, 16, and 24 weeks

• changes in answering diabetes knowledge questions

  from baseline to 8, 16, and 24 weeks

• changes in answering hypertension knowledge questions

  from baseline to 8, 16, and 24 weeks

Study Arms (2)

Technology-based self-management model

EXPERIMENTAL

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

Conventional self-management

NO INTERVENTION

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.

Interventions

Technology-based self-management model DEVICE

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.

Technology-based self-management model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• with abnormal vision and physical impairments
• with any unstable or life-threatening illness

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong, China

Location

Related Publications (5)

• 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.

  PMID: 23612015 BACKGROUND

• 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.

  PMID: 18577730 BACKGROUND

• 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.

  PMID: 15983311 BACKGROUND

• 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.

  PMID: 16139163 BACKGROUND

• 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.

  PMID: 32217498 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Calvin Or, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 15, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)