Diabetes Mellitus Type 2NCT02504086
Online Support for Diabetes Self-Management
A study testing Online Support in people with Diabetes Mellitus Type 2, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of online support for diabetes self-management for patients with Type II diabetes in the Vancouver region. Patients will be invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare providers (video calls in a secure Website). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Online Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Aug 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years to 80 years
- Current diagnosis of Type 2 Diabetes diagnosed at least 6 months previous to the intervention
- Have seen their participating family physician of the Vancouver Coastal Health Authority catchment area at least twice over the last two years, with at least one of those visits including the code for diabetes.
- English Speaking
- Ability to review the consent form independently
- Have access to the online video teleconsultation and personal health record from their home
- Have basic computer literacy (use a computer and the internet at least once a week)
Who cannot join
- Physical disability that precludes normal internet use
- Diagnosis of a terminal illness
- Pregnancy, planning a pregnancy, or currently lactating
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver primary care offices
Vancouver, British Columbia, V6T 2B5
About this study
The purpose of this study is to evaluate the effect of online support for diabetes self-management for patients with Type II diabetes in the Vancouver region. Patients will be invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare providers (video calls in a secure Website). Participants will also have access to the use of an online personal health record -- a place to store healthcare information for the patient and healthcare provider to view. Patients' ability to care for their diabetes will be measured at the beginning and the end of the study. Additional measures include glycaemic control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy, patient satisfaction with care and perceived ease of use and perceived usefulness of the technology.
Read the detailed description
Purpose:
The purpose of this study is to evaluate the effectiveness of a 3-month control-theory-based online support intervention consisting of 8 online video teleconsultations and access to a secure online personal health record on self-management behaviours of adults with type 2 diabetes, as measured by the Summary of Diabetes Self-Care Activities (SDSCA). Secondary outcomes will include glycemic control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy, patient satisfaction with care and perceived ease of use and perceived usefulness of the technology.
Hypothesis:
Patients who receive online support for diabetes self-management and access to an online personal health record will have higher self-management of diabetes scores after they receive the intervention compared to before the intervention.
Justification:
In British Columbia (BC), an estimated 10.3 percent of the population is expected to have diabetes by 2020, at an estimated cost to the BC healthcare system of 1.9 billion dollars per year. Enhancing diabetes self-management has been estimated to be the single most cost-effective intervention in the primary care setting. Results of telemedicine interventions for management of diabetes have been mixed; many interventions show promising improvement in health behaviours, self-efficacy and glycaemic control, while others show small or no effects. A 2015 meta-analysis of the clinical effectiveness of telemedicine randomized controlled trials for type 2 diabetes found a significant decrease in HbA1C overall, with the largest decrease being amongst Internet-based interventions. A recent Cochrane systematic review and meta-analysis of computer-based self-management interventions for adults with type 2 diabetes found that interventions using mobile phones showed a greater reduction in glycaemic control than did the telehealth interventions overall. A meta-regression of techniques in 122 healthy eating and physical activity self-management interventions for diabetes found that self-monitoring explained the greatest amount of among-study heterogeneity, accounting for 13% of these differences. Self-monitoring is a component of control theory, which proposes that in order to effectively manage behaviour, there must be a clear, realistic goal, an action plan for attaining it, a means of monitoring whether a person is on track, feedback, and opportunities for reviewing goals in the light of feedback. Providing additional information for behavioural providers through an online personal health record, and integrating behavioural support with ongoing primary care through shared action plans, the effectiveness of behavioural support provided online may be increased. Standard treatment primarily involves management of diabetes through medications and may involve referral to a diabetes education centre for education about diabetes self-management. The best method to support patient self-management has not been clearly identified.
Objectives:
The specific outcome to be examined is self-management of type II diabetes as measured by the Summary of Diabetes Self-Care Activities (SDSCA).
Research Method:
A pre-post intervention study with a multicentre cohort of 125 patients who will be provided with an online support intervention and followed over three months to evaluate change in diabetes self-management behaviours and clinical outcomes. We will recruit a total of 125 patients with type 2 diabetes through 12 participating primary care physicians. After consent is obtained, participants will be provided with training to use the glucometer, online video teleconsultation tools and online personal health record.
Online Support Intervention:
The online support intervention is designed as a supplement to usual care provided by the family physician, and will be delivered via the Internet through the company Treatment, Inc. a West Vancouver-based provider of patient self-care solutions and services (see Treatment Diabetes Screen shots). The three-month online support intervention involves two primary components to facilitate patient self-management: 8 online video teleconsultations with a certified health professional (for a total of 2.5 hours, weekly at first, then bi-monthly) and access to an online personal health record to promote health care behavioural change. Certified healthcare professionals will provide the 8 online video teleconsultations and will provide reports to the primary care provider as needed and at the end of the 3-month intervention. Participants will also be given a glucose meter (Bayer Contour® Next meter) from which glucose readings can be uploaded to the online personal health record. The patient will use their own glucometer strips as provided by the BC government prescription plan.
Data Collection:
The primary outcome is change in diabetes self-management behaviour as measured by the Summary of Diabetes Self-Care Activities (SDSCA) which includes diet, exercise, self-monitoring of blood glucose, foot care and smoking. Secondary outcomes include change in HbA1C, BMI and waist circumference, diabetes self-efficacy, satisfaction with care, and acceptance of using technology for online support. (See attached document: Measurement Instruments) The primary care provider will have access to the patient's online information, including self-monitored glucose values, for review. Participants will complete online questionnaires at baseline and at end of study.
Sample Size Calculation:
The statistical power for the study was modeled with a two-tailed paired sample t-test to test changes in SDSCA from baseline to three months. Published studies using the SDSCA have shown effects sizes of change in intervention groups ranging from .278 to .53. Thus, conservatively estimating an effect size of .278, to achieve 80% power at a p <.05 significance level, a sample of 125 participants will be required, assuming a 20% longitudinal attrition rate. Attrition rates in the 10% to 20% range have been reported in previous similar Web-based intervention studies.
Data Analysis:
Two-tailed paired sample t-tests will be performed to test for changes in mean self-management behaviours from baseline to three months. Correlations will explore relations between the outcome variables and health literacy, computer literacy and the control variables. Changes across time in the secondary outcomes (clinical outcomes, diabetes self-efficacy) will also be examined using paired-sample t-tests to explore for trends and effect sizes for future studies. All tests will be performed using SPSS version 23, with a p <.05 significance level.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Online Support
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online SupportBehavioural
3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals
| Study group | Role | What they receive |
|---|---|---|
| Online Support | Experimental | 3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals Receives: Behavioral: Online Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diabetes self-management behaviours as measured by Summary of Diabetes Self Care Activities (SDSCA; Toobert et al 2000)
as measured by Summary of Diabetes Self Care Activities (SDSCA; Toobert et al 2000)
Measured: baseline and 3 months
Secondary outcomes (6)
Change in glycemic control as measured by HbA1C
as measured by HbA1C
Measured: baseline and 3 months
Change in body mass index as calculated by patient self-reported height and weight
as calculated by patient self-reported height and weight
Measured: baseline and 3 months
Change in waist circumference as measured by patient using provided instructions
as measured by patient using provided instructions
Measured: baseline and 3 months
Change in Diabetes Self-Efficacy as measured by Diabetes Empowerment Scale, short-form (Anderson et al., 2003)
as measured by Diabetes Empowerment Scale, short-form (Anderson et al., 2003)
Measured: baseline and 3 months
Change in Patient Satisfaction with Care as measured by Patient Assessment of Chronic Illness Care (PACIC)(Glasgow et al., 2005; Schmittdiel et al., 2008)
as measured by Patient Assessment of Chronic Illness Care (PACIC)(Glasgow et al., 2005; Schmittdiel et al., 2008)
Measured: baseline and 3 months
Perceived usefulness and perceived ease of use of online support as measured by the Unified Theory of the Acceptance and Use of Technology (UTAUT) for telehealth (Kohnke et al., 2014 based on Venkatesh et al., 2003)
as measured by the Unified Theory of the Acceptance and Use of Technology (UTAUT) for telehealth (Kohnke et al., 2014 based on Venkatesh et al., 2003)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Difficulty recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Leanne Currie, University of British Columbia
- Investigators
- Leanne Currie, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504086
- Sponsor's protocol ID
- F14-01764
- Status last verified
- Jul 2016
- First submitted
- 24 Jun 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Support for Diabetes Self-Management
- ClinicalTrials.gov ID
- NCT02504086
- Acronym / sponsor ID
- F14-01764
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting participants
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 21 Jul 2015 (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.
The purpose of this study is to evaluate the effect of online support for diabetes self-management for patients with Type II diabetes in the Vancouver region. Patients will be invited to receive 8 online video consultations (total 2.5 hours) with certified healthcare providers (video calls in a secure Website). Participants will also have access to the use of an online personal health record -- a place to store healthcare information for the patient and healthcare provider to view. Patients' ability to care for their diabetes will be measured at the beginning and the end of the study. Additional measures include glycaemic control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy, patient satisfaction with care and perceived ease of use and perceived usefulness of the technology.
Detailed description
Purpose:
The purpose of this study is to evaluate the effectiveness of a 3-month control-theory-based online support intervention consisting of 8 online video teleconsultations and access to a secure online personal health record on self-management behaviours of adults with type 2 diabetes, as measured by the Summary of Diabetes Self-Care Activities (SDSCA). Secondary outcomes will include glycemic control, BMI, waist circumference, diabetes self-efficacy, computer and health literacy, patient satisfaction with care and perceived ease of use and perceived usefulness of the technology.
Hypothesis:
Patients who receive online support for diabetes self-management and access to an online personal health record will have higher self-management of diabetes scores after they receive the intervention compared to before the intervention.
Justification:
In British Columbia (BC), an estimated 10.3 percent of the population is expected to have diabetes by 2020, at an estimated cost to the BC healthcare system of 1.9 billion dollars per year. Enhancing diabetes self-management has been estimated to be the single most cost-effective intervention in the primary care setting. Results of telemedicine interventions for management of diabetes have been mixed; many interventions show promising improvement in health behaviours, self-efficacy and glycaemic control, while others show small or no effects. A 2015 meta-analysis of the clinical effectiveness of telemedicine randomized controlled trials for type 2 diabetes found a significant decrease in HbA1C overall, with the largest decrease being amongst Internet-based interventions. A recent Cochrane systematic review and meta-analysis of computer-based self-management interventions for adults with type 2 diabetes found that interventions using mobile phones showed a greater reduction in glycaemic control than did the telehealth interventions overall. A meta-regression of techniques in 122 healthy eating and physical activity self-management interventions for diabetes found that self-monitoring explained the greatest amount of among-study heterogeneity, accounting for 13% of these differences. Self-monitoring is a component of control theory, which proposes that in order to effectively manage behaviour, there must be a clear, realistic goal, an action plan for attaining it, a means of monitoring whether a person is on track, feedback, and opportunities for reviewing goals in the light of feedback. Providing additional information for behavioural providers through an online personal health record, and integrating behavioural support with ongoing primary care through shared action plans, the effectiveness of behavioural support provided online may be increased. Standard treatment primarily involves management of diabetes through medications and may involve referral to a diabetes education centre for education about diabetes self-management. The best method to support patient self-management has not been clearly identified.
Objectives:
The specific outcome to be examined is self-management of type II diabetes as measured by the Summary of Diabetes Self-Care Activities (SDSCA).
Research Method:
A pre-post intervention study with a multicentre cohort of 125 patients who will be provided with an online support intervention and followed over three months to evaluate change in diabetes self-management behaviours and clinical outcomes. We will recruit a total of 125 patients with type 2 diabetes through 12 participating primary care physicians. After consent is obtained, participants will be provided with training to use the glucometer, online video teleconsultation tools and online personal health record.
Online Support Intervention:
The online support intervention is designed as a supplement to usual care provided by the family physician, and will be delivered via the Internet through the company Treatment, Inc. a West Vancouver-based provider of patient self-care solutions and services (see Treatment Diabetes Screen shots). The three-month online support intervention involves two primary components to facilitate patient self-management: 8 online video teleconsultations with a certified health professional (for a total of 2.5 hours, weekly at first, then bi-monthly) and access to an online personal health record to promote health care behavioural change. Certified healthcare professionals will provide the 8 online video teleconsultations and will provide reports to the primary care provider as needed and at the end of the 3-month intervention. Participants will also be given a glucose meter (Bayer Contour® Next meter) from which glucose readings can be uploaded to the online personal health record. The patient will use their own glucometer strips as provided by the BC government prescription plan.
Data Collection:
The primary outcome is change in diabetes self-management behaviour as measured by the Summary of Diabetes Self-Care Activities (SDSCA) which includes diet, exercise, self-monitoring of blood glucose, foot care and smoking. Secondary outcomes include change in HbA1C, BMI and waist circumference, diabetes self-efficacy, satisfaction with care, and acceptance of using technology for online support. (See attached document: Measurement Instruments) The primary care provider will have access to the patient's online information, including self-monitored glucose values, for review. Participants will complete online questionnaires at baseline and at end of study.
Sample Size Calculation:
The statistical power for the study was modeled with a two-tailed paired sample t-test to test changes in SDSCA from baseline to three months. Published studies using the SDSCA have shown effects sizes of change in intervention groups ranging from .278 to .53. Thus, conservatively estimating an effect size of .278, to achieve 80% power at a p <.05 significance level, a sample of 125 participants will be required, assuming a 20% longitudinal attrition rate. Attrition rates in the 10% to 20% range have been reported in previous similar Web-based intervention studies.
Data Analysis:
Two-tailed paired sample t-tests will be performed to test for changes in mean self-management behaviours from baseline to three months. Correlations will explore relations between the outcome variables and health literacy, computer literacy and the control variables. Changes across time in the secondary outcomes (clinical outcomes, diabetes self-efficacy) will also be examined using paired-sample t-tests to explore for trends and effect sizes for future studies. All tests will be performed using SPSS version 23, with a p <.05 significance level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Support | Experimental | Behavioral: Online Support3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women 18 years to 80 years
- Current diagnosis of Type 2 Diabetes diagnosed at least 6 months previous to the intervention
- Have seen their participating family physician of the Vancouver Coastal Health Authority catchment area at least twice over the last two years, with at least one of those visits including the code for diabetes.
- English Speaking
- Ability to review the consent form independently
Key exclusion criteria (3 listed)
- Physical disability that precludes normal internet use
- Diagnosis of a terminal illness
- Pregnancy, planning a pregnancy, or currently lactating
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 |
|---|---|---|
| Online Support3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals | Behavioural | Online Support |
Primary outcome
Change in diabetes self-management behaviours as measured by Summary of Diabetes Self Care Activities (SDSCA; Toobert et al 2000)
Time frame: baseline and 3 months
as measured by Summary of Diabetes Self Care Activities (SDSCA; Toobert et al 2000)
6 secondary outcomes
Change in glycemic control as measured by HbA1C
Time frame: baseline and 3 months
Change in body mass index as calculated by patient self-reported height and weight
Time frame: baseline and 3 months
Change in waist circumference as measured by patient using provided instructions
Time frame: baseline and 3 months
Change in Diabetes Self-Efficacy as measured by Diabetes Empowerment Scale, short-form (Anderson et al., 2003)
Time frame: baseline and 3 months
Change in Patient Satisfaction with Care as measured by Patient Assessment of Chronic Illness Care (PACIC)(Glasgow et al., 2005; Schmittdiel et al., 2008)
Time frame: baseline and 3 months
Perceived usefulness and perceived ease of use of online support as measured by the Unified Theory of the Acceptance and Use of Technology (UTAUT) for telehealth (Kohnke et al., 2014 based on Venkatesh et al., 2003)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Difficulty recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- 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.
Leanne Currie, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Support in people with Diabetes Mellitus Type 2, run by University of British Columbia at 1 site in Canada.
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 3 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: stopped early, as of the sponsor's last update on 19 Jul 2016. 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 Canada. 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 was stopped early (reason given: Difficulty recruiting participants). Results are not available in the source record.
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 diabetes self-management behaviours as measured by Summary of Diabetes Self Care Activities (SDSCA; Toobert et al 2000) (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2016.