- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02504086
Online Support for Diabetes Self-Management
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 2B5
- Vancouver primary care offices
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in glycemic control as measured by HbA1C
Time Frame: baseline and 3 months
|
as measured by HbA1C
|
baseline and 3 months
|
Change in body mass index as calculated by patient self-reported height and weight
Time Frame: baseline and 3 months
|
as calculated by patient self-reported height and weight
|
baseline and 3 months
|
Change in waist circumference as measured by patient using provided instructions
Time Frame: baseline and 3 months
|
as measured by patient using provided instructions
|
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
|
as measured by Diabetes Empowerment Scale, short-form (Anderson et al., 2003)
|
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
|
as measured by Patient Assessment of Chronic Illness Care (PACIC)(Glasgow et al., 2005; Schmittdiel et al., 2008)
|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leanne Currie, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F14-01764
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Diabetes Mellitus Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on Online Support
-
Gunther MeinlschmidtSelfapy GmbHUnknownCOVID-19 | Mental Health | Psychosocial StressGermany
-
Temple UniversityCancer Support Community, Research and Training Institute, PhiladelphiaCompletedBreast NeoplasmsUnited States
-
McGill University Health Centre/Research Institute...Canadian Institutes of Health Research (CIHR); University of AlbertaActive, not recruitingParent-Child Relations | Autism Spectrum Disorder | Parenting | Mental Health Wellness 1 | Parent-child Problem | Child Development Disorder | Child Developmental DelayCanada
-
British Columbia Cancer AgencyUniversity of British Columbia; McMaster University; University of Calgary; Tom... and other collaboratorsUnknown
-
University of the PhilippinesPhilippine Dermatological SocietyCompleted
-
Universidad de los Andes, ChileMunicipalidad de Lo Barnechea, ChileRecruiting
-
University College, LondonCompletedDepression | Anxiety | Loneliness | Anxiety Disorder | Low MoodUnited Kingdom
-
FHI 360CompletedHIV/AIDS | Medication Adherence | Health Behavior | Adolescent BehaviorNigeria
-
Columbia UniversityCompletedCOVID-19 | MS (Multiple Sclerosis) | Support GroupsUnited States
-
Queen's University, BelfastUniversity of Sheffield; University of Glasgow; University of South Wales; Baily...Recruiting