Type 2 Diabetes MellitusNCT02799953
Technology-augmented Self-monitoring Model Among Patients With Type 2 Diabetes and Hypertension
A study testing Technology-based self-management model in people with Type 2 Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypertension
- What is being tested?
- Technology-based self-management model
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- with abnormal vision and physical impairments
- with any unstable or life-threatening illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Being tested
- Technology-based self-management model
- Keywords
- diabetes mellitus and hypertension, consumer health information technology, self-monitoring, randomized controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-based self-management modelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in HbA1c
Measured: from baseline to 12 and 24 weeks
changes in systolic and diastolic blood pressure
Measured: from baseline to 8, 16, and 24 weeks
Secondary outcomes (5)
medication adherence
Measured: from baseline to 8, 16, and 24 weeks
adherence to diabetes self-care activities
Measured: from baseline to 8, 16, and 24 weeks
adherence to hypertension self-care activities
Measured: from baseline to 8, 16, and 24 weeks
changes in answering diabetes knowledge questions
Measured: from baseline to 8, 16, and 24 weeks
changes in answering hypertension knowledge questions
Measured: from baseline to 8, 16, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Calvin Or, The University of Hong Kong
- Investigators
- Calvin Or, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799953
- Sponsor's protocol ID
- HMRF12133231
- Status last verified
- Oct 2017
- First submitted
- 6 Jun 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23612015Green 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.
PubMed 18577730McMahon 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.
PubMed 15983311Doig 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.
PubMed 16139163Or 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.
PubMed 32217498
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02799953
- Acronym / sponsor ID
- HMRF12133231
- Conditions
- Type 2 Diabetes Mellitus, Hypertension
- Keywords
- diabetes mellitus and hypertension, consumer health information technology, self-monitoring, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-based self-management model | Experimental | Device: Technology-based self-management modelParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- with abnormal vision and physical impairments
- with any unstable or life-threatening illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-based self-management modelParticipants 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. | Device | Technology-based self-management model |
Primary outcome
changes in HbA1c
Time frame: from baseline to 12 and 24 weeks
changes in systolic and diastolic blood pressure
Time frame: from baseline to 8, 16, and 24 weeks
5 secondary outcomes
medication adherence
Time frame: from baseline to 8, 16, and 24 weeks
adherence to diabetes self-care activities
Time frame: from baseline to 8, 16, and 24 weeks
adherence to hypertension self-care activities
Time frame: from baseline to 8, 16, and 24 weeks
changes in answering diabetes knowledge questions
Time frame: from baseline to 8, 16, and 24 weeks
changes in answering hypertension knowledge questions
Time frame: from baseline to 8, 16, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 23612015Or 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.
- Background: PubMed 18577730Green 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.
- Background: PubMed 15983311McMahon 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.
- Background: PubMed 16139163Doig 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.
- Derived from this study: PubMed 32217498Or 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvin Or, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-based self-management model in people with Type 2 Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in HbA1c (time frame: from baseline to 12 and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799953, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.