Diabetes MellitusNCT01066130
Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
A study testing Intensive individualized psychosocial treatment and Minimal treatment arm in people with Diabetes Mellitus and Arthritis, Rheumatoid, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills
- What is being tested?
- Intensive individualized psychosocial treatment and Minimal treatment arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2001to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Center for Family and Community Medicine
Huddinge, 14183
Karolinska University Hospital Solna
Stockholm, 17176
About this study
The aim of this study is to evaluate the results of psychosocial treatment in patients with newly diagnosed rheumatoid arthritis and/or diabetes.
Read the 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.
- Conditions
- Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills
- Being tested
- Intensive individualized psychosocial treatment, Minimal treatment arm
- Keywords
- Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological
- Medical subject headings
- Diabetes Mellitus, Arthritis, Rheumatoid, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive individualized psychosocial treatmentBehavioural
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.
Minimal treatment armBehavioural
Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJan 2001
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Norrbacka-Eugenia Foundation, Swedish Rheumatism Foundation, Svenska Diabetes Association
- Investigators
- Catharina M Gafvels, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066130
- Sponsor's protocol ID
- KI DNR 00-065
- Other IDs
- Other Grant/Funding Number, Other Grant/Funding Number
- Status last verified
- Feb 2010
- First submitted
- 9 Feb 2010
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
- ClinicalTrials.gov ID
- NCT01066130
- Acronym / sponsor ID
- KI DNR 00-065
- Conditions
- Diabetes Mellitus, Arthritis, Rheumatoid, Coping Skills
- Keywords
- Diabetes Mellitus, Arthritis, Rheumatoid, psychosocial aspects, Patient Adherence, Social Work, Coping Behavior, Coping Skills, Adaptation, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Norrbacka-Eugenia Foundation, Swedish Rheumatism Foundation, Svenska Diabetes Association
- Study start
- Jan 2001
- Study completion
- Dec 2005 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment arm | Experimental | Behavioral: Intensive individualized psychosocial treatmentEvery 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. |
| Minimal treatment arm | Experimental | Behavioral: Minimal treatment armEvery second patient with psychosocial problems was assigned to this arm. Patients in this arm received minimal social support by a medical social worker. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive individualized psychosocial treatmentEach 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. | Behavioural | Intensive treatment arm |
| Minimal treatment armMinimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given. | Behavioural | Minimal treatment arm |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catharina M Gafvels, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive individualized psychosocial treatment and Minimal treatment arm in people with Diabetes Mellitus and Arthritis, Rheumatoid, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.