NCT02504086

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

June 24, 2015

Last Update Submit

July 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change in glycemic control as measured by HbA1C

    baseline and 3 months

  • Change in body mass index as calculated by patient self-reported height and weight

    baseline and 3 months

  • Change in waist circumference 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)

    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)

    baseline and 3 months

  • +1 more secondary outcomes

Study Arms (1)

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

Behavioral: Online Support

Interventions

Online SupportBEHAVIORAL

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

Online Support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Physical disability that precludes normal internet use
  • Diagnosis of a terminal illness
  • Pregnancy, planning a pregnancy, or currently lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver primary care offices

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Leanne Currie, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 21, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations