The Effect of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes

BCDiabetes.Ca

Status: Unknown

Conditions: Diabetes Mellitus, Type 2; Psychological Distress

Treatments: Behavioral: Social relationships intervention

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03083795

Love&Support

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Social relationships intervention

Experimental group

Description:

Participants randomized to the social interaction cohort will be split into two groups of 12. Each group of 12 will meet together once a month for a two-hour support group. Each participant will be allowed five minutes to "check-in" with the support group. During the 5 minute period the participant is encouraged to share their innermost thoughts and feelings in the knowledge that this information will not be shared outside the group. Participants will additionally be paired with another study participant in the same cohort and will be asked to meet outside group sessions once a week for a minimum of 45 minutes. The pairing process will take place by study investigators and will be sensitive to gender, age, and neighbourhood of residence. Participants who find that their paired partner is not suitable may ask the facilitators to help find a more suitable match. These participants will continue to receive BC Diabetes standard care.

Treatment:

Behavioral: Social relationships intervention

Control cohort

No Intervention group

Description:

Patients in the control group will receive BC Diabetes standard care.