Diabetes Mellitus, Type 2, Psychological Distress
Conditions
Keywords
Social relationships, Vulnerable connections, Diabetes Distress, Support group
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.
Interventions
BEHAVIORALSocial relationships intervention
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.
Sponsors
BCDiabetes.Ca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1C | 6 months post randomization | Hemoglobin A1C blood test |
| Diabetes distress | 6 months post randomization | Score on Diabetes Distress Screening Scale |
| Self-reported social support | 6 months post randomization | Score on Social Provisions Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight | 6 months post randomization | Weight will be recorded in kilograms |
| 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 |
| 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) |
Contacts
Primary ContactThomas Elliott, MBBS
Backup ContactNoren Z Khamis, BSc
Outcome results
None listed