Strategies to Improve Well-Being and Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Social Identity Threat Concerns (SITC) Scale - Adapted for Diabetes
研究概览
简要总结
This project aims to implement an adapted self-affirmation intervention among a population of individuals with diabetes to reduce the negative psychosocial impacts of stigma. In a self-affirmation, participants are guiding through a writing exercise writing designed to reinforce sources of self-worth before they encounter or engage in stressful or stigmatizing events. Participants in this study will be asked to complete self-affirmation exercises before their 3-month wellness appointments with their endocrinologists over the course of a year. The main questions the investigators are asking are:
- Will self-affirmation reduce feelings of stigmatization?
- Will self-affirmation increase self-efficacy and motivation to engage in condition management behaviors.
- Will self-affirmation improve blood glucose control. Participants will be randomly assigned to either the intervention condition or a waitlist control condition. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.
After each appointment and self-affirmation, participants will complete surveys assessing feelings of stigma and motivation to engage in condition management. All participants will already be using continuous glucose monitors. The investigators will compare both survey responses and continuous glucose data between our conditions to assess the efficacy of the self-affirmation intervention.
详细描述
Upon enrollment, participants will receive an electronic link to an enrollment survey to assess their baseline perceptions of diabetes and weight-based stigma, attitudes towards and intentions to engage in condition management behaviors, sociodemographic and clinical factors (e.g., gender, age, race, and ethnicity) and potential moderators, including diabetes distress, anxiety, depression, history of weight-based victimization, and stigma consciousness. Participants will then be randomly assigned to either the self-affirmation intervention or a waitlist control condition (participants in the waitlist control will have the option to receive the same intervention as participants in the experimental condition at end of the study period). Participants will be using the randomization module in our online survey vendor, REDCap. This module allows researchers to program REDcap to automatically randomize participants in their study to one of the arms or conditions of their study. Before every 3-month wellness visit with their endocrinologist, participants will receive an electronic prompt to complete a self-affirmation writing induction. To complete the writing induction, participants will review a list of values and are instructed to choose up to two that are important to them. Next, participants are asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges. Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it. After their 3-month wellness visit, participants will be sent an electronic link to the post-intervention survey. This will assess to assess their baseline perceptions of diabetes and weight-based stigma, attitudes towards and intentions to engage in condition management behaviors. In total, participants will complete 4 writing inductions and 4 post-evaluation surveys over the course of a year. In addition to writing inductions and survey data, aggregated data from participants' continuous glucose monitors will be collected throughout the study period to assess time spend in target glucose range. The investigators will also collect participants' most recent pre-and-post intervention Hemoglobin A1C (HbA1c) measurements via EHR data to assess longitudinal changes in glucose control. To evaluate the effectiveness of our intervention, the investigators will test whether mean scores in 1) post-intervention stigma and stigma-induced identity threat scores; 2) average confidence in and intentions to engage in condition management scores; and 3) average time spent in target glycemic target range significantly differ between conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants are masked to their assigned condition until the end of the study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management.
- •Participants must be patients of MaineHealth Endocrinology and Diabetes, be at least 18 years of age, have a type 2 diabetes (T2D) diagnosis, and currently use a continue glucose monitor as part of their condition management (Dexcom, FreeStyle Libre).
排除标准
- •Individuals under 18 years of age
研究组 & 干预措施
Self-Affirmation
Participants review a list of values and are instructed to choose up to two that are important to them. The values listed are intentionally unrelated to the threat-inducing domain so that the exercise broadens participants' focus. Next, participants are asked to write a few sentences about why their chosen values are important to them and identify times in which these values have helped them navigate challenges.
干预措施: Self-Affirmation (Behavioral)
Waitlist Control
Participants in the waitlist control condition will also complete writing exercises but they will be abbreviated (this in the psychological literature is referred to as a "low affirmation condition"). At the end of the study, waitlist control participants will have access to the full exercise should they like to receive it.
干预措施: Self-Affirmation (Behavioral)
结局指标
主要结局
Social Identity Threat Concerns (SITC) Scale - Adapted for Diabetes
时间窗: Immediately after each intervention; completed 4 times over the course of a year
Used to assess participants' concerns about experiencing diabetes-specific stigma-induced identity threat while receiving care for T2D. A 1 (Strongly disagree) to 7 (Strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater social identity threat concerns.
Social Identity Threat Concerns (SITC) Scale - Adapted for Weight
时间窗: Immediately after each intervention; completed 4 times over the course of a year
Used to assess participants' concerns about experiencing weight-specific stigma-induced identity threat while receiving care for T2D. A 1 (Strongly disagree) to 7 (Strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater social identity threat concerns.
Diabetes Stigma Assessment Scale
时间窗: Immediately after each intervention; completed 4 times over the course of a year
6-item subscale assessing participants perceived and experienced stigma for use with adults with diabetes. A 1(strongly disagree) to 5 (strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater diabetes stigma.
Diabetes Stigma Assessment Scale - Adapted for weight stigma
时间窗: Immediately after each intervention; completed 4 times over the course of a year
6-item subscale assessing participants perceived and experienced stigma for use with adults with diabetes. We adapted this measure to anchor on internalized weight stigma. A 1(strongly disagree) to 5 (strongly agree) Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater diabetes stigma.
The Revised Diabetes Self-Management Questionnaire
时间窗: Immediately after each intervention; completed 4 times over the course of a year
27-items measure to assess uptake of essential self-management practices for Diabetes. A 0 (Does not apply to me) to 3 (Applies to me very much) Likert response scale is used for all items.
Confidence in Diabetes Self-Care Scale
时间窗: Immediately after each intervention; completed 4 times over the course of a year
20-item measure assessing patient self-efficacy, confidence in ability to perform diabetes self-care tasks. A 1 ("No, I am sure I cannot") to 5 ("Yes, I am sure I can") Likert response scale is used for all items. A composite score is created by summing all items. Higher values indicate greater confidence.
Blood glucose
时间窗: Through study completion, an average of 1 year
Continuous glucose monitor derived indices for time spent in-range
次要结局
- Continuous glucose monitor use(Collected once at time of study enrollment)
- Height(Collected once at time of study enrollment)
- Weight(Collected once at time of study enrollment)
- Years since diagnosis(Collected once at time of study enrollment)
- Diabetes Management Plan(Collected once at time of study enrollment)
- Hemoglobin A1C(Collected once at time of study enrollment and once at study completion)
- Patient-reported age(at end of study (1 year))
- Patient Gender(Collected once at time of study enrollment)
- Patient Race(Collected once at time of study enrollment)
- Patient ethnicity(Collected once at time of study enrollment)
- Patient's highest level of education completed(Collected once at time of study enrollment)
- Household income(Collected once at time of study enrollment)
- Zip code(Collected once at time of study enrollment)
- Physical activity(Collected once at time of study enrollment)
- History of weight-based victimization (moderator/covariate)(Collected once at time of study enrollment)
- Problem Areas in Diabetes Questionnaire (moderator/covariate)(Collected once at time of study enrollment)
- Generalized Anxiety Disorder 7-item (moderator/covariate)(Collected once at time of study enrollment)
- Patient Health Questionnaire (PHQ-9) (moderator/covariate)(Collected once at time of study enrollment)
- Stigma Consciousness Questionnaire (moderator/covariate)(Collected once at time of study enrollment)
- Hemoglobin A1C(Collected once at time of study enrollment and once at study completion)
- Patient-reported age(at end of study (1 year))
- Patient Gender(Collected once at time of study enrollment)
- Patient Race(Collected once at time of study enrollment)
- Patient ethnicity(Collected once at time of study enrollment)
- Patient's highest level of education completed(Collected once at time of study enrollment)
- Household income(Collected once at time of study enrollment)
- Zip code(Collected once at time of study enrollment)
- Years since diagnosis(Collected once at time of study enrollment)
- Diabetes Management Plan(Collected once at time of study enrollment)
- Physical activity(Collected once at time of study enrollment)
- Continuous glucose monitor use(Collected once at time of study enrollment)
- Height(Collected once at time of study enrollment)
- Weight(Collected once at time of study enrollment)
- History of weight-based victimization (moderator/covariate)(Collected once at time of study enrollment)
- Problem Areas in Diabetes Questionnaire (moderator/covariate)(Collected once at time of study enrollment)
- Generalized Anxiety Disorder 7-item (moderator/covariate)(Collected once at time of study enrollment)
- Patient Health Questionnaire (PHQ-9) (moderator/covariate)(Collected once at time of study enrollment)
- Stigma Consciousness Questionnaire (moderator/covariate)(Collected once at time of study enrollment)
- Hemoglobin A1C(Collected once at time of study enrollment, at study completion and 1-year post study completion)
- Weight(Collected once before study completion)
研究者
Elizabeth Scharnetzki
Faculty Scientist I
MaineHealth