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| ID | Type | Description | Link |
|---|---|---|---|
| Other Grant/Funding Number | Other Grant/Funding Number | Norrbacka-Eugeniastiftelsen 811/06 | |
| Other Grant/Funding Number | Other Grant/Funding Number | Reumatikerfonden D:nr 45/05 |
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| Name | Class |
|---|---|
| Norrbacka-Eugenia Foundation | OTHER |
| Swedish Rheumatism Foundation | UNKNOWN |
| Svenska Diabetes Association | UNKNOWN |
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The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.
Research and clinical experience show that adaptation to chronic disease is affected by individuals' psychological and social situations and subjective experiences of threat to identity, autonomy, and life. It is important to identify persons whose psychosocial situation and reaction to the diagnosis is such that they may not be able to adjust to the illness or take adequate responsibility for adherence to treatment.
The purpose of this study is to identify such at-risk persons, and with the help of psychosocial treatment, strengthen their resistance resources and help them work through emotional and social problems that hinder adequate adaptation and adherence to treatment.
Beginning in 2001, 200 consecutive patients between 18 and 65 years who are newly diagnosed with either rheumatoid arthritis (n = 100) or diabetes (n = 100) at the Karolinska Hospital, Solna, Sweden, will be included in the study. Each person will be interviewed by a medical social worker about their psychosocial situation and possible problems. Every other patient with psychosocial problems will be offered intensive, personalized psychosocial treatment. The rest of the patients with problems will be given minimal required measures. The psychosocial well-being and medical situation of all patients (intensive treatment group, minimal treatment group, and the group without need of psychosocial measures) will be followed for 2 years and evaluated at the conclusion of that time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive treatment arm | Experimental | Every second person with psychosocial problems was randomized into this arm. The intervention consisted of personalized, intensive psychosocial treatment provided by a medical social worker on the basis of the patient's problems for up to 2 years after inclusion. |
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| Minimal treatment arm | Experimental | Every second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker. |
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| No need for psychosocial treatment | No Intervention | This arm consisted of individuals who did not need psychosocial treatment or measures. The need for such treatment and measures was determined at baseline for all persons included in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive individualized psychosocial treatment | Behavioral | Each person was given psychosocial treatment and support by a medical social worker a maximum of one time each week for a period of up to 2 years after inclusion. Treatment was designed by a medical social work on the basis of the individual's personal needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychosocial well-being as measured by interview with a medical social worker, Hospital Anxiety and Depression Scale, General Coping Questionnaire, Social Situation Questionnaire, and self-reported satisfaction with psychosocial treatment | 2 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Medical parameters that show whether the patient has reached treatment goals for his or her disease; for example, glycated hemoglobin (HbA1c) for diabetes and the Disease Activity Score (DAS) for rheumatoid arthritis | 2 years after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catharina M Gafvels, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Family and Community Medicine | Huddinge | 14183 | Sweden | |||
| Karolinska University Hospital Solna |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D001172 | Arthritis, Rheumatoid |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Minimal treatment arm | Behavioral | Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given. |
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| Stockholm |
| 17176 |
| Sweden |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |