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Study on ME/CFS by the Hospital of Vestfold in Norway.
The study was approved by the Ethics commitee on the 27th of April 2016. End date is set to late 2019.
English study protocol from page 27
The study was approved by the Ethics commitee on the 27th of April 2016. End date is set to late 2019.
Introduction
Chronic Fatigue Syndrome/Myalgic Encephalopathy (CFS/ME) is characterized by unexplained and disabling fatigue with yet unknown etiology (1, 2).
There is no known treatment to cure the illness. Vestfold Hospital Trust offers three different treatment programs on three different locations, focusing on helping patients cope with their symptoms. The aim for this randomized controlled trial is to evaluate these treatment programs. Results of this trial have an innovation potential in form of better healthcare services in the best interest for the patients.
Background
Based on a prevalence of 0,2 – 0,4 % (1, 3, 4) there are approximately 10000 to 20000 residents with CFS in Norway. The difficulties with definition influence the results of epidemiological studies(1). The core symptom for CFS/ME is persistent fatigue that reduces activity participation. Additional symptoms such as impaired memory and concentration, headache, muscle and joint pain, sleep problems are also common. The overwhelming fatigue is assumed to be the single most important factor for patients substantial impairments (5). In all CFS/ME case definitions, the illness is identified by means of symptoms, disability, and exclusion of explanatory illness, and not by means of physical signs or abnormalities in laboratory test results (1). For patients this condition has a deep impact in everyday life. Living with this illness may lead to sick leave, reduced quality of life, identity crisis and social isolation (6). Experimental studies have demonstrated distinct abnormalities in cardiovascular autonomic control (7, 8) Some reports from Oslo University hospital and University of Oslo, have documented higher blood pressure as compared to healthy controls and a stronger increase of these variables upon orthostatic stress (9-11). There are also reported reduced systolic blood pressure variability during orthostatic stress (12), and abnormal catecholaminergic-dependent thermoregulatory responses with adolescent patients with CFS (13). Similarly, ambulatory measurements of blood pressure and heart rate indicate higher nocturnal values among CFS/ME patients as compared to controls (14). Documentation on effect of treatment for patients with CFS/ME is limited. A systematic review by The Norwegian Knowledge Centre for the Health Services (15) found little relevant research about the effectiveness of rehabilitation for patients with CFS/ME. Previous studies show that cognitive behavioral therapy and graded exercise therapy probably has a positive effect in terms of quality of life (16, 17), but there is less evidence about the treatments effect on return to work or studies. An RCT on treatment may therefore have a great impact for further documentation.
Objectives Knowledge of treatment for patient with CFS/ME is limited, compared to the large number of patients affected. This study aims to accommodate this challenge. The aim is to investigate three different rehabilitation programs at three different locations at Vestfold Hospital Trust. These three programs are: 1. In-hospital rehabilitation program at Clinic physical medicine and rehabilitation 2. Outpatient Self-management program at Clinic medicine 2 3. Outpatient Return to Work (RTW) program at Clinic physical medicine and rehabilitation
Research question:
• Will there be any significant differences in symptoms after treatment
• Will there be any significant differences between the three treatment program by short term effect (1 and 3 month)
• Will there be any significant differences between the three treatment program on long term effect (6, 9 and 12 month)?
The hypothesis is that there will hardly be any significant differences in the three different treatment program on fatigue, quality of life and returned to work or studies (the null hypothesis is not rejected).
Feasibility
The three described interventions is already established as treatment offer at Vestfold Hospital Trust and gives the study good feasability and no need for extra resources to conduct the intervention.
Study design
This study is a randomized, controlled trial with three arms.
Subjects
Patient population is mostly from Vestfold and Telemark, and are between 800 and 1600, based on a prevalence of 0.2 – 0.4 %. Patients will be recruited from general practitioner and outpatient clinic for CFS/ME at Vestfold Hospital Trust and outpatient clinic at Clinic Physical Medicine and Rehabilitaion. For research reason diagnostic criteria for each individual with CFS/ME diagnosis will be labeled. The outpatient clinic for CFS/ME at Vestfold Hospital Trust uses the Canadian definition.
Inclusion criteria:
• Age> 16 year • Recruited from the general practitioners and from the outpatient clinic at Vestfold Hospital Trust.
• Able to take part in all three groups; the in-hospital rehabilitation program, SelfManagement program and Return to work program.
• Patient agrees to participate in the randomized study and informed consent is signed Exlusion criteria: • Age <16 year
• Sever Co morbidity • Not able to participate in the treatment • Not willing to accept random assignment
- Intervention
In the following a brief description of the three different study arms is given.
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The In-hospital rehabilitation
Patients are in hospitalized for a 5 days individual treatment. At admission the patient is examined by a medical specialist together with one or two from the treatment team. Besides ordinary medical evaluation, the patient is given and educational explanation. This is seen as a crucial part of the intervention and an important part of the treatment. Patients are explained how blood pressure, pulse and temperature may work independently in chaos that can lead to imbalance and fatigue. The explanation counts for all theories for etiology. In addition the aim of the first meeting is to establish a good treatment environment for the patient.
The first night at the hospital the patient will get a heart rate monitor /pulse clock which intending to be on for 24 hours. The purpose is to see how the patient is in heart rate for a longer period, and to see if there is natural variation between rests an activity.
The results from the heart rate monitoring will be discusses with the patient.
Patient will be asked to express level of Borg scale after activities as morning care, breakfast, lunch, dinner, night care during the 24 hour heart rate monitoring.
The purpose is to see if there is natural variation between rests and activity in the heart rate monitoring and the levels of Borg scale. The heart rate monitor and Borg scale will also be used in selected activities. First meeting with treatment team, the patients’ challenges and rehabilitation aim will be obtained first or second day, depending on the patients’ capacity. An activity mapping, sorts out important activities for the patient throughout a day, week and month. For the activity mapping Canadian occupational Performance measure (COPM) will be used. COPM is a client- centered measure, designed to detect changes in occupational performance over time (18).
The patient will be tested with 6 min. walking test on a treadmill. The patient is asked to stay within the level 11 and 13 on the Borg scale corresponds pretty easy to just tiring. Borg scale will be explained to the patient prior to the test being performed. Borg scale will be taken immediately after the test time, after 12 hours and 24 hours, the purpose is to measure the delay fatigue (post exertional malaise).
Each patient is given an individual recommendation for activity level and schedule for their stay. This intends to help the patient not to push themselves in activity. Being a “good” patient is not pushing oneself to hard. Resting is equally important as activity.
The Self-Management program
Vestfold Hospital Trust offers a Group based Self-Management program for patients with CFS/ME that promotes coping with the illness in a specialist healthcare setting.
The program runs for 7 weeks, with a two hour session one day a week.
The program covers a number of topics. Each meeting has different themes and lectures/educators. Themes included: Knowledge of the body by a physician, activity pacing and energy conservation by a physiotherapist, how to cope with psychological issues, nutritional approaches by nutritionist, information by patient organization, exchange of individual experiences and information from Norwegian Labour and Welfare Administration (NAV).
RTW program
The treatment is a peer support work, called an expert to expert – interaction where the patient is the expert of his/hers symptoms and situation and the supervisor is expert on normal physiology. The explanation of symptoms is an important part of the program. Symptom is explain as bodily chaos, in the same manner as described in the In-Hospital program. Patients receives information about the program and schedule a time for an initial meeting as soon as possible, preferably within the same week. Patient has the opportunity to bring their significant others to the initial meeting. Individual program and length of patient contact will be adapted according to patient needs.
At the initial meeting patients are given and explanation of the symptom using bodily chaos as an educational approach. This meeting focus on challenges in daily life.
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The introduction course is a two hours information course in the nervous system and normal physiology based on the participant's symptoms. The purpose is to provide knowledge, understanding and insight into normal physiology and what might happen in the body when chaos interferes with the normal physiology. Treatment consist of cognitive techniques, open and reflective questions; what does a day with less chaos look like? What is the difference between a “good” and a less good day? Different tasks whit purpose to help visualize the day with and without chaos. Further supervision follow up will be set in cooperation between the patient and the supervisor. The need for guidance and treatment contacts will be consecutively evaluated.
Randomization procedure
Patients receive orally and written information. After signed consent the patient will be randomized to one of the three study arms and baseline data will be obtained.
Patients are consecutive and with a 1:1 equally randomized, balanced for sex, to (1) in-hospital rehabilitation, (2) attending a outpatient Self management program or (3) attending outpatient Return to work program. The randomization procedure will be performed at a statistical office at Bergen University Hospital that is sited remote from where the study is conducted. Information about the randomizarion will be kept in sealed envelopes and be unknown at baseline examination.
Instruments
Canadian occupational Performance measure (COPM)
The COPM is specificially designed as an aid to facilitate patient participation in the goal formulation process(19). Further more, the COPM is an individualized outcome measure designed to detect change in a client’s self-perception of functioning over time.The administration of the COPM is a stepwise procedure, starting with an interview in which the patient defines his functioning problemes within the areas of self-care, productivity, and leisure. When the item list is completed, the patient is asked to rate the importance of being able to perform each of the identified activities, on a scale from 1 (not important at all) to 10 (extremely important). Finally, the patient rates the most important activities (up to a maximum of 5) regarding both Performance and Satisfatction on a scale ranging from 1 (not able to do, not satisfied at all) to 10 (able to do extremely well, extremely satisfied). Total Performance and Satisfaction scores are calculated by dividing the sum and the scores by the number of reported important activities.
The Fatigue Severety Scale (FSS)
The FSS was originally developed with the purpose of improving the assesment of fatigue and it has proven feasible for assessing change of fatigue (20). The score is a result across seven different statements describing fatigue, for example: “ Fatigue causes frequent problems for me”. Participants are instructed to choose a number from 1 to 5 that indicates their degree og agreement. Total range is 5-35, and higher score indicates ore fatigue.
The Chalder Fatigue Questionnare (CFQ)
The CFQ was suggested as a brief, easy-to –administer, self-rating scale for the assessment fatigue. The score is a results across 11 CFQ items, for example “ Du you need to rest more”, each scored on a 0-3 Likert scale, 0 indicating less than usual and 3 indicating much more than usual. The total range is 0-33; higher score implies more severe fatigue (21).
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English study protocol from page 27
