Clinical trial NCT01066130: Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
Official title: Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Arthritis, Rheumatoid
Coping Skills
Keywords: Diabetes Mellitus
Arthritis, Rheumatoid
psychosocial aspects
Patient Adherence
Social Work
Coping Behavior
Coping Skills
Adaptation, Psychological
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Norrbacka-Eugenia Foundation
name: Swedish Rheumatism Foundation
name: Svenska Diabetes Association
First posted: 2010-02-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: 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
timeFrame: 2 years after inclusion
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Center for Family and Community Medicine
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Karolinska Institutet
name: Catharina M Gafvels, PhD
role: PRINCIPAL_INVESTIGATOR
References: