Using Mobile Phone Short Message Service (SMS) Reminders to Enhance Appointment Attendance in DM Patients

February 14, 2017 updated by: The University of Hong Kong

Using Mobile Phone Short Message Service (SMS) Reminders to Enhance Type 2 Diabetes Mellitus Appointment Attendance in a Primary Care Clinic

A randomized controlled trial of patients with type 2 diabetes mellitus with multiple appointments into short message service group and control group. The attendance rate of these two groups of patients will be compared.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main objective of this study is to evaluate the appointment attendance rate using SMS reminder of nurses and allied health appointments for diabetic patients, when compared to conventional telephone reminder and no reminder. We also aim at determine the factors associated with appointment attendance. Finally, we will also survey patients' acceptance and satisfaction to the SMS service.

This is a single blind randomization study. It will be carried out in Ha Kwai Chung General Outpatient Clinic.

The primary outcome of this study is to evaluate the attendance rate of each individual doctor, nurses and allied health clinic appointments for diabetic patients, as well as their overall attendance rates:

  1. Diabetes Complication Screening Clinic (OPAS DMCS/RDNA)
  2. Diabetes Nurse Intervention Clinic (OPAS DMIC/RDNI)
  3. DM nurse group (OPAS RDNG)
  4. Dietitian Counselling (OPAS DC/DG)
  5. Physiotherapy (OPAS PTC/PTG)
  6. Diabetes Doctor Session (OPAS RDR)
  7. Retino photo Assessment (OPAS RDO)
  8. Blood taking appointment (OPAS LABT)

The secondary outcomes are:

  • Acceptance Rate of SMS Reminder Vs Telephone Reminder Vs no reminder

  • Factors associated with acceptance of SMS

    1. Personal Parameters: Age, sex, educational level, occupation, mobile phone models, Habit of using mobile phone service
    2. Disease Parameters: Number and types of comorbidity, disease control (by biochemical markers)
    3. Quality of Life (by SF-6D)
  • Reported adverse effects of the reminder system
  • Chang in biochemical markers (BMI, HbA1c, LDL-c level) 6-9 months later

Subjects who agreed to participate in this study will first receive a survey on the acceptance of SMS service. For those agree to receive SMS reminder, they will be randomized to:

  1. an SMS remind them to come for scheduled clinic appointment 24-72 hours before, or
  2. usual care with no reminder / telephone reminder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Kwai Chung, Hong Kong, 000
        • Recruiting
        • Ha Kwai Chung General Outpatient Clinic
        • Contact:
        • Principal Investigator:
          • Man Chi Dao, M.B.B.S.
        • Sub-Investigator:
          • Sau Nga Fu, M.B.B.S.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • With diagnosis of type 2 diabetes

  • Have more than 1 clinic services appointment under RAMP-DM programme:

    (e.g. blood taking, diabetic nurse individual counselling, group education, diabetic complication screening, retinal photo assessment, dietician counselling, etc)

Exclusion Criteria:

  1. Cannot read or receive appointment schedule on mobile phone
  2. Do not speak Cantonese/English or read Chinese/English
  3. Mentally incapacitated
  4. Pregnant Women

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SMS group
receive a mobile phone text reminder for scheduled clinic appointment 24-72 hours before,
Other: Mobile phone text message reminder
an SMS remind subjects to come for scheduled clinic appointment 24-72 hours before
No Intervention: Usual care group
Usual care, either telephone reminder or no reminder

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance Rate of the scheduled clinic appointment
Time Frame: between booking time and appointment time, usually within 1 weeks to 16 weeks
Attendance Rate
between booking time and appointment time, usually within 1 weeks to 16 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Authority, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Man Chi Dao, M.B.B.S., Resident

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KW/EX-16-104(100-10)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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