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

Not Applicable

• Conditions: Psychological Distress; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Social relationships intervention

• Registration Number: NCT03083795
• Lead Sponsor: BCDiabetes.Ca

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.

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-17
• Last Update Submitted: 2017-03-17
• Study First Posted: 2017-03-20
• Last Update Posted: 2017-03-20
• Study Start: 2017-04
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social relationships intervention	Social relationships intervention	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.

Primary Outcome Measures

Name	Time	Method
Diabetes distress	6 months post randomization	Score on Diabetes Distress Screening Scale
A1C	6 months post randomization	Hemoglobin A1C blood test
Self-reported social support	6 months post randomization	Score on Social Provisions Scale

Secondary Outcome Measures

Name	Time	Method
Medical adherence	6 months post randomization	Participants will indicate their level of medication adherence on a scale of 1-5. To do this, they will respond to the question "To what extent do you agree with the following statement: I reliably take my diabetes-related medication", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5
Statin refusal	6 months post randomization	Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment)
Exercise	6 months post randomization	Participants will score their exercise on a scale of 1-5. To do this, they will respond to the question "I currently get enough exercise", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5
Weight	6 months post randomization	Weight will be recorded in kilograms
Diet	6 months post randomization	Participants will score their diet on a scale of 1-5. To do this, they will respond to the question " I currently have a good diet", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5
Blood pressure	6 months post randomization	Blood pressure