Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 主要终点
- Diabetes distress
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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;
结局指标
主要结局
Diabetes distress
时间窗: 6 months post randomization
Score on Diabetes Distress Screening Scale
A1C
时间窗: 6 months post randomization
Hemoglobin A1C blood test
Self-reported social support
时间窗: 6 months post randomization
Score on Social Provisions Scale
次要结局
- Weight(6 months post randomization)
- Medical adherence(6 months post randomization)
- Statin refusal(6 months post randomization)
- Exercise(6 months post randomization)
- Diet(6 months post randomization)
- Blood pressure(6 months post randomization)
研究者
Tom Elliott
Medical Director at BC Diabetes
BCDiabetes.Ca