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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Psychological Distress

Intervention / Treatment
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* Behavioral: Social relationships intervention


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social relationships intervention<br>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. | Behavioral: Social relationships intervention<br>* 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.<br>|
| No Intervention: Control cohort<br>Patients in the control group will receive BC Diabetes standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A1C | Hemoglobin A1C blood test | 6 months post randomization | 
| Diabetes distress | Score on Diabetes Distress Screening Scale | 6 months post randomization | 
| Self-reported social support | Score on Social Provisions Scale | 6 months post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure | 6 months post randomization | 
| Medical adherence | 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 | 6 months post randomization | 
| Statin refusal | Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment) | 6 months post randomization | 
| Diet | 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 | 6 months post randomization | 
| Exercise | 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 | 6 months post randomization | 
| Weight | Weight will be recorded in kilograms | 6 months post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social relationships, Vulnerable connections, Diabetes Distress, Support group