Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04611074
Other study ID # HRQL1
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 22, 2019
Est. completion date March 1, 2023

Study information

Verified date March 2023
Source Nordic Clinic Stockholm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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?).


Description:

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. The components in the treatment programme have been investigated separately. Any supplements used are produced by reputable organisations and most of them have been part of the treatment routine for several years. The aims of the study is to evaluate improvement during and after treatment and to identify predictors of recovery. The goal is to understand the process of recovery with the long term goal to improve care given at the clinic. Aim and research question 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?). Methods Study population and inclusion criteria All Swedish speaking patients (>1= 18 years) visiting the clinic will be asked to participate in the study by clinic personnel when visiting the clinic. All patients at the clinic are able to provide informed consent and to fill out online forms. Procedure This is an observational study where patients are followed over time in terms of symptom burden and health related quality of life. The study participants are asked to fill out forms once a month for one year counting from the first visit, and once again 2 years after baseline. Clinical data is collected from the medial record by the clinician at the end of the study. Questionnaires (Jylhä 2009)(K, S et al. 2003)(Westerlund, Brandt et al. 2014)(Smets, Garssen et al. 1995)(Andreasson, Wicksell et al. 2016)(Spitzer, Kroenke et al. 2006)(Spitzer, Kroenke et al. 1999) Clinical variables Information on diagnosis, number of visits, tests and test results, treatment programme and background information (including age, gender, lifestyle factors, readiness for change, education, occupation, social support, height and weight, blood pressure), will be collected from the medical record of the patient by the clinician at the end of the study period. Statistics Based on experience of these types of analyses, 150 participants would give a reasonable foundation for the statistical analyses. 300 unique patients are expected to enrol during the study inclusion period and expect 200 of these to complete at least the first year of data collection. In the main analysis of the first aim, the effect of time on questionnaire scores will be investigated using mixed effect linear regression to see to what extent symptom burden and health related quality of life is affected during treatment and to investigate the stability in any improvements. Secondly, it will be investigated it a high adherence to the treatment programme is associated with improvement. Thirdly, the level of adherence to the treatment programme will be compared between patients with predominant abdominal symptoms and patients with predominant fatigue. In the main analysis of the second aim, readiness for change will be tested as a moderator of the effect of time on questionnaire scores. Secondly, the level of improvement will be compared between patients who self-fund the treatment programme and patients with funding from employer or health insurance. Patients often present with a range of different symptoms. Principal component analysis will be performed in an exploratory analysis to investigate if there are subgroups within the patient population, and if these subgroups differ in terms of treatment response. Covariation over time of symptoms, health related quality of life and self-rated health will be investigated in exploratory analyses. Ethical considerations The present study poses little risk to the participant. The treatment programme that the participant would undergo independently of the study is considered safe with few and mild side effects such as rash. As part of the study the participant report health information on a web questionnaire. Health data is sensitive information and the same platform will be used as for all other data collected by the clinic for treatment. The platform that is used is certified safe (add information) and complies to the GDPR regulation. Risk of missing serious diagnoses When dealing with symptoms such as persistent fatigue there is a risk that serious conditions such as cancer might be missed. However, the risk is estimated as low as low as in primary care at a Vårdcentral. Our medical doctor is still active in primary health care in parallel to Nordic Clinic and has many years of experience. Most of the patients at Nordic Clinic have been thoroughly investigated in the primary care system before signing up as patients at Nordic Clinic. Should patients however present with symptoms that warrant the investigation of serious conditions like malignancies, it is made sure that a thorough investigation has indeed been performed. If it has not, our medical doctor refers them back to primary or specialist health care. Importance There has not been a strong research tradition to evaluate treatment programmes based on functional medicine, albeit the individual components therein have all been evaluated and are found to be safe. However, all treatments given to patients need continuing evaluation. This two-year observational study will provide information regarding treatment outcomes and stability thereof over time, in addition to identifying patient groups that get the most benefit of the treatment. Future randomised controlled trials are needed to evaluate the effectiveness of the treatment programme.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - <18 years, non-Swedish speaking

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Nordic Clinic Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Nordic Clinic Stockholm Stockholm University

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

Andreasson A, Wicksell RK, Lodin K, Karshikoff B, Axelsson J, Lekander M. A global measure of sickness behaviour: Development of the Sickness Questionnaire. J Health Psychol. 2018 Sep;23(11):1452-1463. doi: 10.1177/1359105316659917. Epub 2016 Jul 24. — View Citation

Bryant PA, Trinder J, Curtis N. Sick and tired: Does sleep have a vital role in the immune system? Nat Rev Immunol. 2004 Jun;4(6):457-67. doi: 10.1038/nri1369. No abstract available. — View Citation

Hallgren M, Stubbs B, Vancampfort D, Lundin A, Jaakallio P, Forsell Y. Treatment guidelines for depression: Greater emphasis on physical activity is needed. Eur Psychiatry. 2017 Feb;40:1-3. doi: 10.1016/j.eurpsy.2016.08.011. Epub 2016 Nov 10. No abstract available. — View Citation

Jylha M. What is self-rated health and why does it predict mortality? Towards a unified conceptual model. Soc Sci Med. 2009 Aug;69(3):307-16. doi: 10.1016/j.socscimed.2009.05.013. Epub 2009 Jun 10. — View Citation

Rezaie A, Pimentel M, Rao SS. How to Test and Treat Small Intestinal Bacterial Overgrowth: an Evidence-Based Approach. Curr Gastroenterol Rep. 2016 Feb;18(2):8. doi: 10.1007/s11894-015-0482-9. — View Citation

Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737. — View Citation

Westerlund A, Brandt L, Harlid R, Akerstedt T, Lagerros YT. Using the Karolinska Sleep Questionnaire to identify obstructive sleep apnea syndrome in a sleep clinic population. Clin Respir J. 2014 Oct;8(4):444-54. doi: 10.1111/crj.12095. — View Citation

Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209. — View Citation

Younge JO, Gotink RA, Baena CP, Roos-Hesselink JW, Hunink MG. Mind-body practices for patients with cardiac disease: a systematic review and meta-analysis. Eur J Prev Cardiol. 2015 Nov;22(11):1385-98. doi: 10.1177/2047487314549927. Epub 2014 Sep 16. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in gastrointestinal discomfort from baseline as assessed by the Gastrointestinal Symptom Rating Scale for IBS questionnaire (GSRS-IBS) 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. Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in fatigue from baseline as assessed by the Multidimensional Fatigue Inventory 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. Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in health-related quality of life from baseline as assessed by the 36-Item Short Form Health Survey (SF-36) The SF-36 measures physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in sleep from baseline as assessed by the Karolinska Sleep Questionnaire (KSQ) 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). Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in anxiety from baseline as assessed by the Generalised Anxiety Disorder 7-item scale (GAD-7) 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). Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in presence or severity of depression from baseline as assessed by the Patient Health Questionnaire-9 (PHQ-9) 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). Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Primary Change in overall health from baseline as assessed by the Self-rated health questionnaire 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). Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Secondary Correlation between motivation for behavioral change and change in symptom burden and health-related quality of life Correlation between motivation for behavioral change and change in the primary outcome measures Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
Secondary Predictability of the predominance of fatigue or abdominal-related symptomatology for adherence to the treatment programme Correlation between outcome measures in Gastrointestinal Symptom Rating Scale for IBS questionnaire (GSRS-IBS) and adherence to the treatment programme. Baseline (time of enrollment), then each month 1-12 months after baseline, and then at 24 months.
See also
  Status Clinical Trial Phase
Completed NCT03153644 - Improving Contraceptive Care for Women With Medical Conditions
Recruiting NCT06058754 - Group-based [ADAPT] Versus One-to-one [Usual] Occupational Therapy (Go:OT Trial) N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05558085 - Biomarker Cost-Benefit Analysis of EFNEP N/A
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Not yet recruiting NCT05622422 - A Chronic Disease Self Care Management Pilot Study N/A
Not yet recruiting NCT06016101 - Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies
Not yet recruiting NCT04954209 - Comparative Study in Long-term Commitment to Physical Activity After Two Different Resumption Programs
Not yet recruiting NCT04090593 - Chronic Disease Mobile Educational Experience N/A
Not yet recruiting NCT03628963 - Optimizing Patient Usability Experience for Chronic Care N/A
Completed NCT02390570 - Incorporating Patient Capacity Into the Clinical Landscape N/A
Completed NCT02072941 - Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE) N/A
Completed NCT02292940 - Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions
Terminated NCT02115971 - Jumping Exercises Approach in Individuals With Chronic Ankle Instability N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT02017262 - Group Self-Management of Depression and Medical Illness N/A
Completed NCT02307929 - Evaluation of Quality of Care - Nurse Allied Health Clinic Programme, HA N/A
Completed NCT01458184 - Study of PhoneCare System to Treat Patients With Chronic Diseases N/A
Completed NCT00380536 - Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings N/A
Completed NCT00333710 - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD N/A