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

Primary Purpose

Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Intensive individualized psychosocial treatment
Minimal treatment arm
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Family and Community Medicine
  • Karolinska University Hospital Solna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intensive treatment arm

Minimal treatment arm

No need for psychosocial treatment

Arm Description

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.

Every second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 9, 2010
Last Updated
February 9, 2010
Sponsor
Karolinska Institutet
Collaborators
Norrbacka-Eugenia Foundation, Swedish Rheumatism Foundation, Svenska Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01066130
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Norrbacka-Eugenia Foundation, Swedish Rheumatism Foundation, Svenska Diabetes Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills
Keywords
Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive treatment arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Minimal treatment arm
Arm Type
Experimental
Arm Description
Every second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker.
Arm Title
No need for psychosocial treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive individualized psychosocial treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Minimal treatment arm
Intervention Description
Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.
Primary Outcome Measure Information:
Title
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
Time Frame
2 years after inclusion
Secondary Outcome Measure Information:
Title
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
Time Frame
2 years after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catharina M Gafvels, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Family and Community Medicine
City
Huddinge
ZIP/Postal Code
14183
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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