Online Support for Diabetes Self-Management

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Online Support for Diabetes Self-Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02504086
• Other study ID #: F14-01764
• Status: Terminated
• Phase: N/A
• First received: June 24, 2015
• Last updated: July 15, 2016
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: July 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• 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)

Exclusion criteria:

• Physical disability that precludes normal internet use

• Diagnosis of a terminal illness

• Pregnancy, planning a pregnancy, or currently lactating

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Online Support
3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals

Locations

Country	Name	City	State
Canada	Vancouver primary care offices	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline and 3 months	No
Secondary	Change in glycemic control as measured by HbA1C	as measured by HbA1C	baseline and 3 months	No
Secondary	Change in body mass index as calculated by patient self-reported height and weight	as calculated by patient self-reported height and weight	baseline and 3 months	No
Secondary	Change in waist circumference as measured by patient using provided instructions	as measured by patient using provided instructions	baseline and 3 months	No
Secondary	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)	baseline and 3 months	No
Secondary	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)	baseline and 3 months	No
Secondary	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)	3 months	No