A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Mental fatigue score
研究概览
简要总结
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation.
AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention.
METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months.
CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units.
In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.
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
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-72 years old
- •15-72 months since first Graves' diagnosis
- •high free thyroxin and thyroid antibodies (TRAb) at diagnosis
- •euthyroid the last 6 months normal thyroid hormone levels at inclusion
- •symptoms on MF in connection to Graves diagnosis
- •MF-scale ≥10.5 points
排除标准
- •other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease)
- •pregnancy
- •lactation
- •assessment that the patient cannot follow the study protocol.
研究组 & 干预措施
Intervention
Mental Fatigue course + Usual care in clinical care
干预措施: MF course (Other)
Intervention
Mental Fatigue course + Usual care in clinical care
干预措施: Usual health care (Other)
Control Group
Usual care in clinical care
干预措施: Usual health care (Other)
结局指标
主要结局
Mental fatigue score
时间窗: Change from baseline examined at 3 months follow-up.
Scores at the Mental Fatigue Scale are compared between the intervention and the control group. Scores is between 0-42 and higher scores mean more brain fatigue.
次要结局
- Severity score(Change from baseline examined at 12 months follow-up.)
- Levels of thyroid hormones(Change from baseline examined at 12 months follow-up.)
- Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).(Change from baseline examined at 12 months follow-up.)
- Comprehensive psychopathological rating questionnaire (CPRS)(Change from baseline examined at 12 months follow-up.)
- Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)(Change from baseline examined at 12 months follow-up.)
- EuroQol- health questionnaire (EQ-5D)(Change from baseline examined at 12 months follow-up.)
- Frenchay Activities Index (FAI)(Change from baseline examined at 12 months follow-up.)
- Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI).(Change from baseline examined at 6 months follow-up.)
- Mental fatigue score(Change from baseline examined at 12 months follow-up.)
- Coping Orientations to Problems Experienced (Brief cope)(Change from baseline examined at 12 months follow-up.)
- General Self-Efficacy Scale (GSE)(Change from baseline examined at 12 months follow-up.)
- Perceived Stress Scale (PSS-14)(Change from baseline examined at 12 months follow-up.)
- Days of sick-leave and cost related to health care and medication(Change from baseline examined at 12 months follow-up.)
- Levels of thyroid autoantibodies(Change from baseline examined at 12 months follow-up.)
- Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)(Change from baseline examined at 12 months follow-up.)
- Clinical Activity Score (CAS)(Change from baseline examined at 12 months follow-up.)
- Comprehensive psychopathological rating questionnaire (CPRS)(Change from baseline examined at 3 months follow-up.)
- Comprehensive psychopathological rating questionnaire (CPRS)(Change from baseline examined at 6 months follow-up.)
- Coping Orientations to Problems Experienced (Brief cope)(Change from baseline examined at 3 months follow-up.)
- Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)(Change from baseline examined at 3 months follow-up.)
- Coping Orientations to Problems Experienced (Brief cope)(Change from baseline examined at 6 months follow-up.)
- General Self-Efficacy Scale (GSE)(Change from baseline examined at 3 months follow-up.)
- General Self-Efficacy Scale (GSE)(Change from baseline examined at 6 months follow-up.)
- Perceived Stress Scale (PSS-14)(Change from baseline examined at 3 months follow-up.)
- Perceived Stress Scale (PSS-14)(Change from baseline examined at 6 months follow-up.)
- Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)(Change from baseline examined at 3 months follow-up.)
- Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)(Change from baseline examined at 6 months follow-up.)
- Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).(Change from baseline examined at 3 months follow-up.)
- Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).(Change from baseline examined at 6 months follow-up.)
- Days of sick-leave and cost related to health care and medication(Change from baseline examined at 3 months follow-up.)
- EuroQol- health questionnaire (EQ-5D)(Change from baseline examined at 3 months follow-up.)
- EuroQol- health questionnaire (EQ-5D)(Change from baseline examined at 6 months follow-up.)
- Levels of thyroid hormones(Change from baseline examined at 3 months follow-up.)
- Frenchay Activities Index (FAI)(Change from baseline examined at 3 months follow-up.)
- Frenchay Activities Index (FAI)(Change from baseline examined at 6 months follow-up.)
- Days of sick-leave and cost related to health care and medication(Change from baseline examined at 6 months follow-up.)
- Levels of thyroid autoantibodies(Change from baseline examined at 3 months follow-up.)
- Levels of thyroid autoantibodies(Change from baseline examined at 6 months follow-up.)
- Levels of thyroid hormones(Change from baseline examined at 6 months follow-up.)
- Clinical Activity Score (CAS)(Change from baseline examined at 3 months follow-up.)
- Clinical Activity Score (CAS)(Change from baseline examined at 6 months follow-up.)
- Severity score(Change from baseline examined at 3 months follow-up.)
- Severity score(Change from baseline examined at 6 months follow-up.)
- Mental fatigue score(Change from baseline examined at 6 months follow-up.)