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

NCT01066130 | Completed

• 2 other identifiers: KI DNR 00-065Other Grant/Funding Number
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus; Arthritis, Rheumatoid; Coping Skills

Keywords

Diabetes Mellitus; Arthritis, Rheumatoid; psychosocial aspects; Patient Adherence; Social Work; Coping Behavior; Coping Skills; Adaptation, Psychological

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

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.

Behavioral: Intensive individualized psychosocial treatment

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.

Behavioral: Minimal treatment arm

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.

Interventions

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.

Intensive treatment arm

Minimal treatment arm BEHAVIORAL

Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.

Minimal treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Norrbacka-Eugenia Foundation: collaborator
• Swedish Rheumatism Foundation: collaborator
• Svenska Diabetes Association: collaborator

Study Sites (2)

Center for Family and Community Medicine

Huddinge, 14183, Sweden

Location

Karolinska University Hospital Solna

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus; Arthritis, Rheumatoid; Patient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Catharina M Gafvels, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: January 1, 2001
• Study Completion: December 1, 2005
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

SE (2)