跳至主要内容
临床试验/NCT06972251
NCT06972251已完成不适用

Tailored Approaches to Reduce Distress and Improve Self-Management for Veterans With Diabetes (TARDIS) - Photo Elicitation and Intervention

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Diabetes Distress Scale Score

研究概览

简要总结

Veterans with type 2 diabetes (T2D) may become overwhelmed with the self-management behaviors needed to maintain optimal health. Veterans may experience diabetes distress (DD), a concept distinct from depression, due the amount and frequency of these behaviors. Diabetes distress negatively influences the Veteran's engagement in self-management and subsequent glycosylated hemoglobin (HbA1c) levels. Previous interventions aimed at improving T2D self-management and reducing DD do not tailor T2D self-management information to a Veteran's DD, which may be one reason interventions are ineffective at reducing DD.

The purpose of this study is to further understand DD by expanding on what the investigators have learned thus far in cognitive and semi-structured interviews with Veterans (see ClinicalTrials.gov identifier NCT04587336). In Aim 3a, the photo elicitation study, the Veteran would be provided with a camera and instructed to take approximately 20 photos over two weeks. The investigators would conduct two semi-structured interviews with the Veteran to discuss this experience. Visual-based qualitative methods will help us identify and more robustly describe DD in Veterans. In Aim 3b, the investigators will conduct a pilot study of a novel telemedicine intervention.

The TARDIS intervention (Aim 3b) will build off data collected in Aim 3a and provide tailored coaching to Veterans with type 2 diabetes mellitus. The TARDIS intervention includes coaching, self-management information, and referrals to Veterans Health Administration (VHA) supportive services delivered via the telephone. TARDIS will augment current VHA care for patients with diabetes. All Veterans will continue to receive care from their primary clinicians during the study.

详细描述

Background and Significance: An estimated 20-25% of Veterans are diagnosed with diabetes, an incidence three times higher than the national rate. Treatment and management of poorly self-managed diabetes is costly as medical care costs are 2.3 times higher for individuals with diabetes than for those who do not have the disease. Regular preventative care is essential to prevent comorbidities and maintain optimal health. Individuals with T2D provide 99% of their own care; self-management of T2D is person-specific and ever-present. Consistent and sustained self-management decreases comorbidity development, and positively influences quality of life and psychosocial outcomes. Inconsistent self-management increases the risk of poor health outcomes including microvascular and/or macrovascular problems and psychosocial complications. Yet rates of self-management remain sub-optimal.

T2D self-management is omnipresent, inescapable, and burdensome. A Veteran may become overwhelmed and/or frustrated because of the amount and frequency of T2D self-management behaviors, and these negative feelings may lead to inattention to critical self-management behaviors such as eating healthy or blood glucose checks. Veterans often experience challenges to self-management despite knowing the importance of these behaviors. Self-management challenges include limited access to a healthcare provider, unreliable transportation, limited knowledge of healthy food options, beliefs about T2D medications, or a lack of support. Additionally, diabetes distress (DD) and other psychosocial factors (i.e., depression, post-traumatic stress disorder) negatively influence an individual's engagement in self-management and health outcomes. Due to the inherent complexity of T2D self-management, the investigators propose that tailoring on DD is one way to focus the provision of tailored self-management information and connections to supportive services. Diabetes distress encompasses the cognitive, physical, and affective experience of living with T2D. Diabetes distress occurs when an individual is overwhelmed with T2D, related self-management behaviors, and knowledge that T2D is progressive and incurable. Diabetes distress is subjective and person-specific; and while DD may fluctuate over time, DD may be continually present. Undiagnosed and untreated DD, may be one cause of a Veteran's poor self-management, thus resulting in poor health outcomes.

Diabetes distress is commonly assessed via the Diabetes Distress Scale or the Problem Areas in Diabetes Scale. Research indicates both measures demonstrate the construct of DD is distinct from general anxiety, stress, and depression. Both the Diabetes Distress Scale and Problem Areas in Diabetes scales assess DD in several domains, and each DD domain addresses a separate aspect of the burden of T2D. The Diabetes Distress Scale measures DD in four domains (i.e., regimen, emotional, interpersonal, healthcare provider), and the Problem Areas in Diabetes Scale assesses DD using similar domains (i.e., emotional, diabetes management, treatment, and social support burden). The Diabetes Distress Scale and Problem Areas in Diabetes Scale have demonstrated content validity in measuring an individual's perception of the resources available, or not available, for self-management. Diabetes distress is associated with more T2D complications, increased stress, being prescribed insulin by a healthcare provider, poor diet and exercise, inadequate support environments, and is more prevalent among women. Diabetes distress levels correlate with self-management behaviors such as monitoring one's diet, engaging with providers, and monitoring one's blood glucose. High to moderate levels of DD are related to poorer glucose regulation, higher HbA1c, lower medication adherence, and poorer quality of life. Individuals with DD report diabetes-related physical burden, health care system distress, and distress with comorbid conditions. In this study, the investigators will further examine the Veteran's experience of DD.

The TARDIS grant and the prior work done for TARDIS was based upon the original Diabetes Distress Scale (DDS) and the four domains within that scale. Those domains include: regimen, provider, interpersonal, and emotional. In 2022, the authors of the Diabetes Distress Scale published an updated version of the DDS called the Type 2 Diabetes Distress Assessment System (T2D-DDAS). The T2D-DDAS contains core and source items that contribute to DD. The T2D-DDAS sources include: hypoglycemia, long-term health, health care provider, interpersonal issues, shame/stigma, healthcare access, and management demands. The sources or facets of DD the investigators identified in the TARDIS foundational work are reflected in the T2D-DDAS. Of note, the investigators identified several additional facets of DD in our work such as pain, military experience, living with comorbidities, and being a caregiver. The scoring for low, moderate, and high DD in the DDS and the T2D-DDAS is the same. For the TARDIS intervention, the investigators will be focusing on the domains of DD as measured by the DDS and not the sources of DD as measured by the T2D-DDAS. The DDS is in the Cerner electronic health record (EHR) and is being used in the VA and the foundational TARDIS work uses the DDS.

Aim 3a: Visual Based Qualitative Methods Visual-based qualitative methods will help us identify and more robustly describe DD in Veterans and will expand on what the investigators have learned thus far in cognitive and semi-structured interviews. Veterans will have the autonomy to select photos that impact, either positively or negatively, their DD and diabetes self-management behaviors. Veterans who participate in the project may want to share their experiences because this is their personal story which they want to share to help other people. The Veteran has the autonomy to decide what, and how much, information to share.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 2 diabetes (ICD-10 codes: E11.9, E11.8)
  • Documentation of HbA1c drawn within the past 180 days
  • Able to speak and read English
  • Be able to provide informed consent to participate in the study
  • Own a mobile phone with advanced computing capabilities (otherwise known as a smartphone) or mobile device to take photos (Aim 3a only)
  • hemoglobin A1C (HbA1C) test value greater than or equal to 8.5 (Aim 3b only)
  • Be prescribed insulin (Aim 3b only)

排除标准

  • New diagnosis of T2D within the last 60 days
  • Hospitalization for mental illness within the past 30 days
  • Receiving active chemotherapy and/or radiation treatment
  • Diagnosis for metastatic cancer
  • Recent hospitalization within the past 60 days that would influence their diabetes medication regimen (e.g., myocardial infarction, cerebrovascular accident, coronary artery bypass grafting, etc.)
  • Currently receiving kidney dialysis
  • Limited hearing or speech difficulties that influence the Veteran's ability to complete the survey and intervention
  • Dementia, delirium, or other cognition issues that influence the Veteran's ability to provide consent and complete the survey
  • Not currently prescribed insulin (Aim 3b only)

结局指标

主要结局

Diabetes Distress Scale Score

时间窗: Baseline

Scale used: 17 item Diabetes Distress Scale. Minimum value 1, Maximum value 6 Scoring is: \< 2.0 is little or no distress; 2.0-2.9 is moderate distress; and ≥ 3.0 is high distress. Higher scores indicate higher diabetes distress or worse outcome.

HbA1c Value

时间窗: Baseline

The HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.

Photo Elicitation (Aim 3a) Semi-Structured Interviews

时间窗: From consent up to 1 month

Number of semi-structured interviews completed by participants (1 interview per time point per participant)

Diabetes Distress Scale Score

时间窗: Baseline

Scale used: 17 item Diabetes Distress Scale. Minimum value 1, Maximum value 6 Scoring is: \< 2.0 is little or no distress; 2.0-2.9 is moderate distress; and ≥ 3.0 is high distress. Higher scores indicate higher diabetes distress or worse outcome.

HbA1c Value

时间窗: Baseline

The HbA1c value is determined from a blood test that measures a patient's average blood glucose level over the past 2 to 3 months.

Photo Elicitation (Aim 3a) Semi-Structured Interviews

时间窗: From consent up to 1 month

Number of semi-structured interviews completed by participants (1 interview per time point per participant)

次要结局

  • Health Coaching Calls (Aim 3b - TARDIS Intervention)(Coaching calls started two weeks post-baseline to occur up to 3 months after consent)
  • Health Coaching Calls (Aim 3b - TARDIS Intervention)(Coaching calls started two weeks post-baseline to occur up to 3 months after consent)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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