Clinical trial NCT03083795: The Effect of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes
Official title: Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Psychological Distress
Keywords: Social relationships
Vulnerable connections
Diabetes Distress
Support group
Lead sponsor: BCDiabetes.Ca
Sponsor class: NETWORK
First posted: 2017-03-20
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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;

Primary outcomes:
measure: A1C
timeFrame: 6 months post randomization
measure: Diabetes distress
timeFrame: 6 months post randomization
measure: Self-reported social support
timeFrame: 6 months post randomization
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 months post randomization
measure: Medical adherence
timeFrame: 6 months post randomization
measure: Statin refusal
timeFrame: 6 months post randomization
measure: Diet
timeFrame: 6 months post randomization
measure: Exercise
timeFrame: 6 months post randomization
measure: Weight
timeFrame: 6 months post randomization
Other outcomes:
Locations:
Study officials:
affiliation: BC Diabetes, The University of British Columbia
name: Thomas Elliott, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rabi DM, Edwards AL, Southern DA, Svenson LW, Sargious PM, Norton P, Larsen ET, Ghali WA. Association of socio-economic status with diabetes prevalence and utilization of diabetes care services. BMC Health Serv Res. 2006 Oct 3;6:124. doi: 10.1186/1472-6963-6-124.
citation: O'Kane C, O'Kane D. Real: The Power of Authentic Connection. 1st ed. Clearmind publishing; 2016.
citation: Rossi MC, Lucisano G, Funnell M, Pintaudi B, Bulotta A, Gentile S, Scardapane M, Skovlund SE, Vespasiani G, Nicolucci A; BENCH-D Study Group. Interplay among patient empowerment and clinical and person-centered outcomes in type 2 diabetes. The BENCH-D study. Patient Educ Couns. 2015 Sep;98(9):1142-9. doi: 10.1016/j.pec.2015.05.012. Epub 2015 May 21.
citation: Siousioura D. Review of therapeutic groups for type 1 diabetes mellitus patients. J Endocrinol Diabetes 2012;3(2):11-21.
citation: Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Erratum. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care 2016;39:2126-2140. Diabetes Care. 2017 Feb;40(2):287. doi: 10.2337/dc17-er02. Epub 2016 Dec 7. No abstract available.