Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial

BCDiabetes.Ca0 sites48 target enrollmentApril 2017

ConditionsDiabetes Mellitus, Type 2 Psychological Distress

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
Sponsor: BCDiabetes.Ca
Enrollment: 48
Primary Endpoint: Diabetes distress
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study will determine the feasibility and effectiveness of a monthly social support group along with a weekly peer-to-peer meeting in improving perceived level of social support, diabetes distress, and A1c profiles in patients with Type II diabetes mellitus, compared with standard care offered at British Columbia Diabetes (BC Diabetes).

Detailed Description

This is a prospective, randomized, non-blinded comparative group clinical trial of 48 participants receiving social interaction in addition to standard diabetes care or standard diabetes care alone. All participants will have a baseline and 6 month follow-up visit where assessment of their A1C, diabetes distress, and social support will be performed. Participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. In addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. All participants in the social support cohort will continue to receive best standard diabetes management. Participants in the control group will be treated with standard diabetes care. At the end of the 6-month study, they will have the opportunity to engage in the same social interventions offered to the social interaction group.

Registry

clinicaltrials.gov

Start Date

April 2017

End Date

December 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

BCDiabetes.Ca

Responsible Party

Principal Investigator

Tom Elliott

Medical Director at BC Diabetes

BCDiabetes.Ca

Eligibility Criteria

Inclusion Criteria

•Willingly provide your full informed consent to participate;
•Are at least 19 years of age;
•Have an established diagnosis of Type 2 diabetes mellitus;
•Have a Diabetes Distress Screening Scale (a score of 2-3 is considered moderate distress, 3-4 is considered high)
•Have a Social Provisions Scale score less than 60 (a score of 80-90 is considered high, 60-80 moderate and less than 60 sub-optimal)
•Have an A1c greater than 8.5% in the last 2 months (a score of 6-7 is considered optimal, 7-8 sub-optimal and \>8.0 inadequate)

Exclusion Criteria

•Are unable to easily communicate in oral and written English.
•Have a physical disability or psychiatric diagnosis which would limit the ability to participate in the study;
•Are a prisoner, or in pre-trial;
•Do not have a fixed address;