Health-related Quality of Life in Patients at Nordic Clinic

NCT04611074 | Terminated

• 1 other identifier: HRQL1
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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?).

Conditions

Chronic Disease

Keywords

Chronic Disease

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All Swedish speaking patients (\>1= 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.

You may qualify if:

• 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.

You may not qualify if:

• \<18 years, non-Swedish speaking

Sponsors & Collaborators

• Nordic Clinic Stockholm: lead
• Stockholm University: collaborator

Study Sites (1)

Nordic Clinic

Stockholm, 74191, Sweden

Location

Related 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.

  PMID: 27458105 BACKGROUND

• 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.

  PMID: 15173834 BACKGROUND

• 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.

  PMID: 27837666 BACKGROUND

• 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.

  PMID: 19520474 BACKGROUND

• 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.

  PMID: 14531531 BACKGROUND

• 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.

  PMID: 26780631 BACKGROUND

• 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.

  PMID: 7636775 BACKGROUND

• 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.

  PMID: 10568646 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 25396257 BACKGROUND

• 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.

  PMID: 25227551 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annie ML Pettersson, PhD

  Nordic Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: November 2, 2020
• Study Start: August 22, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

SE (1)