Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Therapy rationale and therapy expectancy |
The Credibility Expectancy Questionnaire (CEQ) published by Ametrano, et al. 2011 and validated as German version by Rieke, et al. 2013 is used to measure Therapierationale and Therapieerwartung at baseline. It measures these over 6 items using 9-point Likert scales. |
Week 1 |
|
Other |
Personality dimensions |
Big-Five-Inventory-10 (BFI-10) is used to assess personality dimensions based on the big-5 model. |
Week 1 |
|
Primary |
Fatigue |
The chalder fatigue scale is used to assess the severity of fatigue within the last 4 weeks. It contains 11 questions in a four-step answer format (0-4), 7 of which refer to the degree of physical fatigue and 4 to the degree of mental fatigue. In its binomial evaluation (range 0-11) it can be used with a cut-off of (= 4) to divide patients into those with and those without fatigue. |
12 weeks |
|
Secondary |
Fatigue |
Chalder Fatigue Scale |
24 weeks |
|
Secondary |
Health related quality of life SF-12 |
Short Form 12 Health Survey Questionnaire, The SF-12 represents the most commonly used instrument in clinical trials to assess generic quality of life. The questionnaire captures 8 different subscales, which are combined into a physical and a psychological summated scale. |
12 weeks |
|
Secondary |
Health related quality of life SF-12 |
Short Form 12 Health Survey Questionnaire, The SF-12 represents the most commonly used instrument in clinical trials to assess generic quality of life. The questionnaire captures 8 different subscales, which are combined into a physical and a psychological summated scale. |
24 weeks |
|
Secondary |
Health related quality of life EQ-5D-5L |
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the EQ-5D-5L is used for cost-effectiveness analysis, together with healthcare-related costs. |
12 weeks |
|
Secondary |
Health related quality of life EQ-5D-5L |
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In this study, the EQ-5D-5L is used for cost-effectiveness analysis, together with healthcare-related costs. |
24 weeks |
|
Secondary |
Psychological symptoms |
The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week. |
12 weeks |
|
Secondary |
Psychological symptoms |
The Hospital Anxiety and Depression Scale asks 14 questions, of which 7 are about anxiety and 7 about depression in patients with physical illnesses and physical complaints. More precisely, it measures the self-assessed severity of patients' anxious and depressive symptoms in relation to the past week. |
24 weeks |
|
Secondary |
Sleep quality |
The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. |
12 weeks |
|
Secondary |
Sleep quality |
The Pittsburgh Sleep Quality Index (PSQI) assesses the quality of sleep over the past 4 weeks using 24 questions, 17 for self-assessment and 7 for external assessment. It is used clinically to monitor patients with sleep disorders and to screen for sleep disorders in epidemiological studies. |
24 weeks |
|
Secondary |
Stress |
The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items. |
12 weeks |
|
Secondary |
Stress |
The current stress perception of the patients is assessed by means of the Perceived Stress Scale (PSS-10). This measures the current subjective perceived stress of the patients on the basis of 10 items. |
24 weeks |
|
Secondary |
Post-exertional malaise |
Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM. |
12 weeks |
|
Secondary |
Post-exertional malaise |
Post-exertional malaise (PEM) is a delayed worsening of symptoms that occurs after minimal physical or mental activity. The DePaul-Symptom Questionaire (DSQ) is used to asses PEM. |
24 weeks |
|
Secondary |
Body awareness |
The BAQ is an 18-item scale designed to assess self-reported attentiveness to normal nonemotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions. Body awareness will be used in mediation analyses of treatment effects. |
12 weeks |
|
Secondary |
Body awareness |
The BAQ is an 18-item scale designed to assess self-reported attentiveness to normal nonemotive body processes, specifically, sensitivity to body cycles and rhythms, ability to detect small changes in normal functioning, and ability to anticipate bodily reactions. Body awareness will be used in mediation analyses of treatment effects. |
24 weeks |
|
Secondary |
Self-Efficacy |
The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects. |
12 weeks |
|
Secondary |
Self-Efficacy |
The Arthritis Self-Efficacy Scale (ASES) was originally developed in 1989 as part of the Stanford Arthritis Self-Management Study to assess self-efficacy in arthritis patients and has since been used to assess it in many disease conditions. A short version (ASES-8/ASES-D) has been validated. This version surveys in scale level 1-10 the perceived ability to deal with occurring symptoms such as: Pain or fatigue. Self-efficacy will be used in mediation analyses of treatment effects. |
24 weeks |
|
Secondary |
Adverse events |
Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). The severity as well as the possible causal relationship with the intervention will be assessed by the study physician. |
12 weeks |
|
Secondary |
Adverse events |
Adverse events and serious adverse events are documented. Adverse events include any adverse symptoms, illnesses, disorders, or accidents that occur during the course of the study. Serious adverse events include events occurring during the course of the study that are immediately life-threatening and/or result in serious health problems (specifically, requiring unanticipated hospitalization or prolongation of hospitalization, or resulting in serious disability or incapacitation). The severity as well as the possible causal relationship with the intervention will be assessed by the study physician. |
24 weeks |
|
Secondary |
C-reactive proteine |
CRP as marker of pro-inflammatory cytokine activity, from blood samples. |
12 weeks |
|
Secondary |
C-reactive proteine |
CRP as marker of pro-inflammatory cytokine activity, from blood samples. |
24 weeks |
|
Secondary |
Interleukine-6 |
IL-6, as marker of pro-inflammatory cytokine activity, from blood samples. |
12 weeks |
|
Secondary |
Interleukine-6 |
IL-6, as marker of pro-inflammatory cytokine activity, from blood samples. |
24 weeks |
|
Secondary |
D-dimer |
D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample |
12 weeks |
|
Secondary |
D-dimer |
D-dimer, as a by-product of the blood clotting and break-down process that can be measured via analysis of a blood sample |
24 weeks |
|
Secondary |
Lactate dehydrogenase |
Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use. |
12 weeks |
|
Secondary |
Lactate dehydrogenase |
Lactate dehydrogenase (LDH), measuring the amount of LDH in the blood. Lactate dehydrogenase is an enzyme that the body uses during the process of turning sugar into energy for your cells to use. |
24 weeks |
|
Secondary |
Leukocytes and lymphocytes |
Leukocytes and lymphocytes, from blood samples. |
12 weeks |
|
Secondary |
Leukocytes and lymphocytes |
Leukocytes and lymphocytes, from blood samples. |
24 weeks |
|
Secondary |
Grip strength |
Repeated measurement of hand strength can help detect physical decline and inflammatory processes Hand strength measurement can be an invaluable tool for monitoring physical performance decline. |
12 weeks |
|
Secondary |
Grip strength |
Repeated measurement of hand strength can help detect physical decline and inflammatory processes Hand strength measurement can be an invaluable tool for monitoring physical performance decline. |
24 weeks |
|
Secondary |
Movement tracking |
General tracking of patients' movement habits via activity monitor |
12 weeks |
|
Secondary |
Movement tracking |
General tracking of patients' movement habits via activity monitor |
24 weeks |
|
Secondary |
Heart rate variability |
HRV is simply a measure of the variation in time between each heartbeat. This variation is controlled by a primitive part of the nervous system called the autonomic nervous system (ANS). It works behind the scenes, automatically regulating our heart rate, blood pressure, breathing, and digestion among other key tasks. |
12 weeks |
|
Secondary |
Heart rate variability |
HRV is simply a measure of the variation in time between each heartbeat. This variation is controlled by a primitive part of the nervous system called the autonomic nervous system (ANS). It works behind the scenes, automatically regulating our heart rate, blood pressure, breathing, and digestion among other key tasks. |
24 weeks |
|