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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Odense University Hospital | OTHER |
| University of Copenhagen | OTHER |
| Musculoskeletal Statistics Unit, The Parker Institute |
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Chronic diseases are currently the most prevalent and most costly health conditions world-wide, and morbidity is expected to increase over coming years. Factors such that increased life-expectancy and certain life style-related factors, such as smoking, high-fat diet and alcohol-consumption, are commonly associated with the increase in most of the common chronic diseases. However, more complex psychosocial factors such as depression, stress, work-related dynamics and thinking patterns are thought be associated with poor health status and impaired health related quality of life among patients with suffering from chronic physical conditions (i.e. a biopsychosocial approach). Therefore, psychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions.
The aim of this randomized trial is to evaluate the effectiveness of mind-body multidisciplinary rehabilitation on health-related quality of life, and disease specific endpoints in people with rheumatoid arthritis, psoriasis, or heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Intervention: | Active Comparator | Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program) |
|
| No Intervention | No Intervention | No intervention (Study participants will receive routine clinical practice) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-Body Approaches for Medical Conditions | Behavioral | The intervention programme of the present trial is delivered in a group-based format (15 participants per group) and overall applies three therapeutic components:
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| Measure | Description | Time Frame |
|---|---|---|
| WHO-Five Well-being Index | All participants. The WHO-5 consists of five statements. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| SF36: Physical Component Summary (PCS) | All participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity score 28 based on C-reactive protein (DAS28-CRP) | Rheumatoid Arthritis. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Tender joints | Rheumatoid Arthritis.28 joints palpates with a 4 kg pressure. The patient state the perception on pain on a scale from 1-10 cm. A higher score indicates higher pain. |
Inclusion Criteria:
Rheumatoid arthritis:
Psoriasis:
Heart Failure with reduced ejection fraction:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Khoury Aerts, PhD | Contact | 0045 61660623 | lkho0011@regionh.dk | |
| Lone Skov, Professor | Contact | 0045 38673204 | lone.skov.02@regionh.dk |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D011565 | Psoriasis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| UNKNOWN |
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| SF36: Mental Component Summary (MCS) | All participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Illness Perception Questionnaire | All participants. Every item is rated using a 0-10 response scale, a higher score reflecting a more threatening view of the illness. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Pittsburgh sleep quality index | All participants. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| High-sensitivity C-reactive protein (hs-CRP) | All participants. Blood sample | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Mindful Attention Awareness Scale-5 | All participants. To score the scale, simply compute a mean of the 15 items. Higher scores reflect higher levels of dispositional mindfulness | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Self-Compassion Scale | All participants. As a rough guide, a score of 1-2.5 for your overall self-compassion score indicates you are low in self-compassion, 2.5-3.5 indicates you are moderate, and 3.5-5.0 means you are high. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Cohen's Perceived Stress Scale | All participants. ► Scores ranging from 0-13 would be considered low stress. ► Scores ranging from 14-26 would be considered moderate stress. ► Scores ranging from 27-40 would be considered high perceived stress | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Hospital anxiety and depression scale (HADS) | All participants. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher score indicates worse depression or anxiety. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Swollen joints | Rheumatoid Arthritis. Assessed by a train physician. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| VAS-Pain | Rheumatoid Arthritis. Score range from 1-100. Higher score indicates worse pain. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| VAS-Patient global assessment | Rheumatoid Arthritis. using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Psoriasis Area and Severity Index | Psoriasis. ASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 to 72.Higher score indicates worse psoriasis. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Physician Global Assessment (PGA) | Psoriasis. Scores range from 100 (extremely high functioning) to 1 (severely impaired). | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Dermatology Life Quality Index (DLQI) | Psoriasis. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| Kansas City Cardiomyopathy Questionnaire | Heart Failure with reduced ejection fraction. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |