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Coronary Artery DiseaseNCT02883842

Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study

A study testing Text messaging in people with Coronary Artery Disease and Diabetes, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among coronary heart… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Coronary Artery Disease, Diabetes
What is being tested?
Text messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
1 siteChina
Study dates
Aug 2016to Nov 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with coronary artery disease defined as history of myocardial infarction and PCI
  • History of diabetes
  • Capability to read and send text messages

Who cannot join

  • Assumed poor adherence
  • Do not have an active mobile phone

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Patients With Coronary Heart Disease and Diabetes in China: Cardiovascular Health and Text Messaging-Diabetes Mellitus (CHAT-DM) Study

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among coronary heart disease (CHD) patients with diabetes. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 6 pre-designed text messages per week in addition to usual care for 6 months, while the control group will receive usual care.

Read the detailed description

Objective: This study aims to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among CHD patients with diabetes. We hypothesized that an intervention using mobile phone text based education and reminder can improve risk factors control and medication adherence for CHD patients.

Study design: The study is a two-arm, parallel, randomized clinical trial. Patients will be eligible if they have documented CHD defined as having history of myocardial infarction and percutaneous coronary intervention (PCI), have a history of diabetes mellitus, have the capability of reading and sending short message, and are able to provide informed consent. Patients will be excluded if they do not have an active mobile phone. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive intervention of pre-designed text messages in addition to usual care, while the control group will receive usual care. All the participants will be followed up for 6 months.

Study intervention: Participants in the intervention group will receive text messages for 6 months as well as usual care. They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week.

Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C) as measured by central blood sample. Secondary endpoints include a change in proportion of patients achieving HbA1C<7%, body mass index (BMI), physical activity, medication adherence, systolic blood pressure, low-density lipoprotein cholesterol (LDL-C) and fasting blood glucose (FBG). Exploratory endpoints include long-term prognosis of the patients, such as death, nonfatal myocardial infarction, stroke and so on, as well as health status (SAQ and EQ-5D).

Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Being tested
Text messaging
Keywords
Coronary artery disease, Diabetes, Text messages
Medical subject headings
Coronary Artery Disease, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text messagingBehavioural

    Patients will receive regular semi-personalized text messages for 6 months. Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am, 12noon, 4.00pm). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week. Prior to study commencement, a bank of 270 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.

Study groups in NCT02883842
Study groupRoleWhat they receive
Intervention-Text messagingExperimentalPatients will receive regular semi-personalized text messages for 6 months. Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am, 12noon, 4.00pm). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week.
Receives: Behavioral: Text messaging
ControlNo interventionParticipants in the control group will receive 2 thank-you messages per month and undertake routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glucose level measured by HbA1C level

    We will measured the change in glucose level from baseline to 6 months.

    Measured: Baseline; 6 months

Secondary outcomes (7)

  1. Change in proportion of patients achieving HbA1C<7%

    We will measure the change in proportion of patients achieving HbA1C<7% from baseline to 6 months.

    Measured: Baseline; 6 months

  2. Change in level of fasting blood glucose (FBG)

    We will measure the change in FBG level from baseline to 6 months.

    Measured: Baseline; 6 months

  3. Change in body mass index (BMI) according to national standards

    We will measured the change in BMI from baseline to 6 months.

    Measured: Baseline; 6 months

  4. Change in systolic blood pressure (SBP) obtained in office during each interview

    We will measured the change in SBP from baseline to 6 months.

    Measured: Baseline; 6 months

  5. Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale

    We will measure the change in IPAQ scale from baseline to 6 months.

    Measured: Baseline; 6 months

  6. Change in medication adherence

    We will measure the change in medication adherence from baseline to 6 months.

    Measured: Baseline; 6 months

  7. Change in low-density lipoprotein cholesterol (LDL-C) level

    We will measure the change in LDL-C level from baseline to 6 months.

    Measured: Baseline; 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02883842
Sponsor's protocol ID
201502009-2
Status last verified
May 2018
First submitted
24 Aug 2016
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Huo X, Krumholz HM, Bai X, Spatz ES, Ding Q, Horak P, Zhao W, Gong Q, Zhang H, Yan X, Sun Y, Liu J, Wu X, Guan W, Wang X, Li J, Li X, Spertus JA, Masoudi FA, Zheng X. Effects of Mobile Text Messaging on Glycemic Control in Patients With Coronary Heart Disease and Diabetes Mellitus: A Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Sep;12(9):e005805. doi: 10.1161/CIRCOUTCOMES.119.005805. Epub 2019 Aug 31.

    PubMed 31474119

  • Huo X, Spatz ES, Ding Q, Horak P, Zheng X, Masters C, Zhang H, Irwin ML, Yan X, Guan W, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes. BMJ Open. 2017 Dec 21;7(12):e018302. doi: 10.1136/bmjopen-2017-018302.

    PubMed 29273661

Questions about this trial

What is this clinical trial studying?

A study testing Text messaging in people with Coronary Artery Disease and Diabetes, run by China National Center for Cardiovascular Diseases 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 3 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 11 May 2018. 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?

Change in glucose level measured by HbA1C level (time frame: Baseline; 6 months). 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 NCT02883842, which also lists 2 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 11 May 2018.

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