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| ID | Type | Description | Link |
|---|---|---|---|
| 2011/894/REK nord | Registry Identifier | REK nord | |
| 36IAJ3 | Other Grant/Funding Number | Extra Stiftelsen Helse og Rehabilitering |
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| Name | Class |
|---|---|
| Stiftelsen Helse og Rehabilitering | OTHER |
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The aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with Chronic Fatigue Syndrome (CFS)in primary healthcare.
In an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual.
The results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.
The project is a single blind randomized controlled trial. A total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. The 75 participants in the intervention group will be allocated to 6 groups. The control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will be offered to take part in the patient education group as soon as they have completed the last outcome evaluations | |
| Patient education program | Experimental | Patient education program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education program | Behavioral | Patient education program, 8 meetings, every other week, 2,5 hours per meeting. |
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| Measure | Description | Time Frame |
|---|---|---|
| SF-36, subscale Physical functioning. | Measures change in physical functioning. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Illness Management Questionnaire (IMQ). | Measures change in ways of coping with CFS. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The SF-36 (total score and subscale role limitations due to physical limitations). | The SF-36 total score measures change in functional status related to health. The subscale measures change in role limitations due to physical limitations. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Unni Sveen, Ph.d. | Oslo University Hospital | Study Director |
| Irma Pinxsterhuis, M.Sc. | Oslo University Hospital | Principal Investigator |
| Dag Kvale, Ph.d. | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irma Pinxsterhuis | Oslo | 0424 | Norway |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| Fatigue Severity Scale (FSS). |
Measures change in fatigue-related severity, symptomatology, and functional disability. |
| T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Illness Cognition Questionnaire (ICQ) | Measure change in helplessness, acceptance, and perceived benefits. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| The Fennell Phase Inventory (FPI) | Measures change in coping and progression through four phases: crisis phase, stabilization phase, resolution phase, and integration phase. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Hospital Anxiety and Depression Scale (HADS) | Measures change in anxiety and depression. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Perceived Stress Scale (PSS)- 10 items | Measures change in global perceived stress. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Brief Illness Perception Questionnaire (BIPQ) | Measures change in cognitive and emotional representations of illness. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Self-efficacy Scale (SE24) | Measures change in perceived control with respect to CFS complains. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| Self-defined fatigue and pain scale | Measures change in perceived fatigue and pain. | T0: Baseline, T1: After 4 months, T2: After 10 months, T3: After 16 months. |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |