The Feasibility, Acceptability and Preliminary Effectiveness of an Internet-based Intervention for Diabetes Distress in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The proportion of eligible patients who agree to participate in the interventions throughout the study period
研究概览
简要总结
This study will investigate whether an online intervention can be helpful in reducing diabetes distress in people with type 1 diabetes and elevated diabetes distress, compared to individual counselling sessions (online, phone-based or face-to-face, depending on the preference of the person with type 1 diabetes). Half of the participants will receive the online intervention, while the other half will receive individual counseling sessions with a psychologist.
Objectives: The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress, in comparison with individual counselling sessions.
Hypotheses: The investigators predict that both interventions will be feasible to use, shown by how many people join, stay engaged, and complete the interventions. The investigators also think that people will find both interventions acceptable, as shown by the positive feedback given in interviews after they finish.
详细描述
Individuals with diabetes are primarily responsible for managing their disease. Therefore, their ability to effectively self-treat their diabetes is critical for their prognosis. These significant treatment responsibilities place considerable demands on individual patients. These demands can lead to high levels of diabetes distress. Diabetes distress encompasses the emotional distress arising from the constant self-care burden that is required to self-manage diabetes, but also feelings of insufficient support and understanding from others, and challenges in communication with healthcare professionals. Diabetes distress is prevalent among individuals with diabetes. International research indicates that approximately 20-25% of individuals with diabetes experience high levels of diabetes distress. Studies exploring the impact of diabetes distress on diabetes management reveal that significant diabetes distress not only diminishes overall well-being but also correlates with suboptimal self-management of diabetes. This includes insufficient physical activity, unhealthy dietary choices, reduced medication adherence, infrequent blood glucose monitoring, and elevated HbA1c levels.
At Steno Diabetes Center Odense (SDCO), there are provisions for individual psychological intervention aimed at patients facing psychological challenges associated with their diabetes. However, due to resource constraints, priority is given to those patients experiencing the most severe impact.
As part of a new initiative at SDCO, Patient-Reported Outcome (PRO) data has been incorporated alongside diabetes same-day micro- and macrovascular complication screening, which includes an assessment of mental well-being (i.e. diabetes distress). These assessments will contribute to higher recognition rates of elevated diabetes distress, thereby exacerbating the strain on already limited resources available for individual psychological intervention. Moreover, not all patients may have the requisite time, necessity, or opportunity to partake in such individual intervention.
In order to expand existing psychological services at SDCO in an affordable way, an online psychological intervention needs to be developed. The objective of the online psychological intervention is to cater to a larger group of people with type 1 diabetes, who can autonomously engage with evidence-based components of the intervention, thereby averting the progression of patients' diabetes distress towards adverse or pathological conditions, such as anxiety or depression. Studies indicate that therapist-supported online therapy yields comparable efficacy to traditional face-to-face therapy. Additionally, online therapy offers the benefit of flexibility, allowing patients to engage with the intervention at their convenience, thereby obviating the need for patients to take time away from their professional commitments to attend sessions with a psychologist.
Aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A total score or a score on one of the subscales of the Diabetes Distress Scale for type 1 diabetes which is 2 or above.
- •Diagnosed with type 1-diabetes ≥ 12 months ago.
- •Age ≥ 30 years.
- •Receiving treatment at SDCO.
- •Proficiency in Danish and basic IT skills.
排除标准
- •Psychiatric diagnosis that may compromise participation in the intervention e.g. psychosis, schizophrenia, substance or alcohol abuse.
- •Cognitive impairments that may compromise participation in the intervention e.g. dementia, Alzheimer's, brain injury.
- •Complex issues best suited for individual treatment as assessed by the clinical psychologist.
结局指标
主要结局
The proportion of eligible patients who agree to participate in the interventions throughout the study period
时间窗: Throughout the duration of the study approx. 12 months
The number of eligible patients who agree to participate in the interventions
The completion rates of survey measures at pre- and post-intervention and at three months follow-up
时间窗: Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
The number of patients completing the survey measures at pre- and post-intervention as well as at three months follow-up
Characteristics of patients receiving the interventions and those who drop out assessed through survey data.
时间窗: Throughout study participation, an average of 6 months
Patient characteristics assessed through survey data
Acceptability of the online intervention expressed by patients
时间窗: After completion of the intervention, an average of 3-12 months
Will be assess by expressions of patients through qualitative semi structured interviews
Acceptability of the online intervention expressed by participating clinical staff
时间窗: Obtained after study completion approx.12 months
Will be assess by expressions of participating clinical staff through qualitative semi structured interviews
Time points of log ins on the platform
时间窗: Obtained after completion of the online intervention, an average of 3-6 months
The time points of log ins to the platform by patients in the online intervention during their access to the platform
Number of messages sent between patients and psychologist
时间窗: Obtained after completion of the online intervention, an average of 3-6 months
The number of messages sent between the patients in the online intervention and their psychologist
Number of log ins on the platform
时间窗: Obtained after completion of the online intervention, an average of 3-6 months
The number of log ins on the platform by patients in the online intervention
Numbers of hours spend on the platform
时间窗: Obtained after completion of the online intervention, an average of 3-6 months
The number of hours the patients in the online intervention spend on the platform during their access to the platform
Numbers of modules completed in the online intervention
时间窗: Obtained after completion of the online intervention, an average of 3-6 months
The number of modules completed by the patients in the online intervention
次要结局
- Diabetes Distress Scale for type 1 diabetes (T1 DDS)(Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention)
- Estimated HbA1c(Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention))
- Acceptance & Action Diabetes Questionnaire (AADQ-6)(Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention)
- The Patient Activation Measure (PAM)(Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention)
- Time below range (TBR) is the percentage of time the blood glucose levels is below the recommended target range(Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention))
- The DAWN (Diabetes Attitudes, Wishes and Needs study) Impact of Diabetes Profile (DIDP)(Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention)
- Negative Effect Questionnaire (NEQ)(Immediately after the intervention)
- System Usability Scale (SUS)(Immediately after the online intervention)
- Time in range (TIR) is the percentage of time the blood glucose levels in the recommended target range(Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention))
- Time above range (TAR) is the percentage of time the blood glucose levels is above the recommended target range(Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention))
