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临床试验/NCT01066130
NCT01066130已完成不适用

Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2001年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
4
主要终点
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

研究概览

简要总结

The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed diabetes (within one month of receiving diagnosis)
  • newly diagnosed rheumatoid arthritis(within one month of receiving diagnosis)
  • patient at the endocrinological or rheumatical clinic at the Karolinska University Hospital, Solna, Sweden

排除标准

  • patients previously diagnosed with diabetes (had been diagnosed more than a month ago)
  • patients previously diagnosed with rheumatoid arthritis (had been diagnosed more than a month ago)
  • inability to speak Swedish well enough to fill in standard questionnaires

结局指标

主要结局

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

时间窗: 2 years after inclusion

次要结局

  • 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)

研究者

申办方类型
Other

研究点 (4)

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