Health-related Quality of Life and Symptom Burden in Patients at Nordic Clinic Before, During and After Personalised, Functional Medicine Treatments and Lifestyle Interventions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in fatigue from baseline as assessed by the Multidimensional Fatigue Inventory
研究概览
简要总结
Nordic Clinic is a private clinic for personalised treatment based on the Functional Medicine concept. In summary, functional medicine is aimed at addressing the lifestyle and behavioral factors that are believed to contribute to the symptoms the patient suffers from. In short, the treatment is based on a timeline of health-related life events, current lifestyle factors and behaviors and physiological examinations to develop a personalised lifestyle program. The main component of the treatment provided at Nordic Clinic is in-depth lifestyle coaching to achieve the desired behavioral and lifestyle changes.
Working at the clinic is a clinical physiologist, nutritionist, physician specialist in general medicine and researchers work. The vast majority of people who apply for the clinic have long-standing symptoms that have been investigated by the healthcare system without any organic explanation for the symptoms having been identified. Common causes are gastrointestinal problems, persistent fatigue and insomnia. The aim of the study is to investigate symptom-borne and health-related quality of life during and after treatment and to identify predictors of improvement of health-related quality of life. The main purpose is to investigate whether the health-related quality of life is improved during treatment. This is an observational study and all adult patients who are able to complete the web form in Swedish at the clinic are asked to participate. Participants who give consent will receive a link to the questionnaire via email once a month for one year and once after two years. Participants are recruited for two years, and will be completed after the last questionnaire is completed by the last included participant, ie autumn 2022. In addition to the self-assessments, the number of visits to the clinic, sampling and results, who finances the treatment and treatment plan are recorded.
The first aim is to investigate improvement in symptom burden and health related quality of life during and after treatment (does symptom burden and health related quality of improve during treatment and are improvements stable at the 2 year follow-up?) The second aim is to investigate factors that predict recovery (Do persons with a high level of motivation for behavioural change experience a better improvement in symptom burden and health related quality of life than persons with a low level of motivation for behavioural change?).
详细描述
Research plan
Health related quality of life in patients at the Nordic Clinic
Background
Nordic Clinic is a private clinic that provides personalised treatment based on functional medicine. The vast majority of the patients seeking care at the clinic suffer from unexplained medical symptoms, most commonly fatigue and abdominal symptoms, and have previously been medically evaluated by health care. Working at the clinic are a clinical physiologist, nutritional therapist, licensed physician and a researcher. Patients follow a clinical treatment process starting with the physician progressing through to the nutritionist. Treatment is covered either by the patient themselves, by employers or health insurances.
Before treatment is initialised, an extensive medical history along with current lifestyle habits are taken. The treatment programme is based on lifestyle factors, mainly diet, sleep, stress management and physical activity. Supplements are given. Drugs are prescribed sparsely and by a licenced physician, and may include Rifaximin or other antibiotics for intestinal bacterial overgrowth, motility drugs for constipation, anti-parasitic drugs in case of parasite infection, and melatonin for sleep disturbances.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All Swedish speaking patients (>/= 18 years) visiting the clinic will be asked to participate in the study by clinic personnel when they are visiting the clinic. All patients at the clinic are able to provide informed consent and to fill out online forms.
排除标准
- •<18 years, non-Swedish speaking
结局指标
主要结局
Change in fatigue from baseline as assessed by the Multidimensional Fatigue Inventory
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
General fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue is evaluated on a scale from 1-5, where 1 is true and 5 is not true.
Change in anxiety from baseline as assessed by the Generalised Anxiety Disorder 7-item scale (GAD-7)
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
GAD-7 is a self-assessment form that measures seven anxiety-related symptoms using the following scale: Not at all (0), Several days (1), More than half the days (2), Nearly every day (3).
Change in health-related quality of life from baseline as assessed by the 36-Item Short Form Health Survey (SF-36)
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
The SF-36 measures physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Change in sleep from baseline as assessed by the Karolinska Sleep Questionnaire (KSQ)
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
KSQ is a self-assessment form that measures difficulty falling asleep, disturbed sleep, repeated awakenings, early wakings, difficulty waking up, insufficient rest during the night, nightmares, snoring, daytime effects. The questionnaire contains 13 questions about sleep and sleepiness which are answered according to a five-point scale from 1 (never/very good) to 5 (always/very bad).
Change in presence or severity of depression from baseline as assessed by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
PHQ-9 screens for presence or severity of depression according to the DSM-IV criteria. It measures nine depression-related symptoms using the following scale: Not at all (0), Several days (1), More than half the days (2), Nearly every day (3).
Change in gastrointestinal discomfort from baseline as assessed by the Gastrointestinal Symptom Rating Scale for IBS questionnaire (GSRS-IBS)
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Self-reported satiety, abdominal pain, diarrhoea, constipation and bloating is measured with GSRS-IBS with the following outcomes: No discomfort at all, Minor discomfort, Mild discomfort, Moderate discomfort, Moderately severe discomfort, Severe discomfort, Very severe discomfort.
Change in overall health from baseline as assessed by the Self-rated health questionnaire
时间窗: Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
The self-rated health questionnaire is a single question questionnaire, evaluating overall health at the time of the survey using the scale very good" (1), "good" (2), "moderate" (3), "bad" (4) or "very bad" (5).
次要结局
- Predictability of the predominance of fatigue or abdominal-related symptomatology for adherence to the treatment programme(Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.)
- Correlation between motivation for behavioral change and change in symptom burden and health-related quality of life(Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.)