The aim of the study is to show the effectiveness of tailored cognitive-behavioral E-health care for risk groups of patients with rheumatoid arthritis in comparison to usual care.
ID
Bron
Verkorte titel
Aandoening
Rheumatoid arthritis
Reumatoïde artritis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the impact of the rheumatic disease on daily life, including its impact on physical and psychological functioning and daily activities at post-treatment and follow-up measurements after 9, 12, 15 and 18 months.
<br><br>
The primary outcome measures are measured as follows:<br>
1. Impact on physical functioning: composite z-scores of<br>
A. Pain (IRGL, Huiskes, 1990);<br>
B. Fatigue (CIS, Vercoulen, 1996).<br>
2. Impact on psychological functioning: composite z-scores of:<br>
A. Negative mood (IRGL, Huiskes, 1990);<br>
B. Anxiety (IRGL, Huiskes, 1990);<br>
C. Depression (BDI, Beck, 1988).<br>
3. Impact on daily activities: composite z-scores of<br>
A. Mobility and self-care (IRGL, Huiskes, 1990);<br>
B. Role limitations due to emotional and physical health problems (SF-36. Ware, 1993).
Achtergrond van het onderzoek
In the present project, the effects of tailored E-health cognitive-behavior care are studied for patients with rheumatoid arthritis. In a randomized, controlled trial, rheumatoid arthritis patients are screened for psychological risk profiles. Patients at risk will be randomized to E-health cognitive-behavioral treatment care or a control condition with care as usual (without E-health or face-to-face cognitive-behavioral E-health care). It is expected that the E-health cognitive-behavioral care will be effective for the impact of the disease on physical and psychological functioning and daily activities at post-treatment and follow-up assessments. Secondary outcomes include cost-effectiveness as well as effects on disease severity and treatment compliance.
Doel van het onderzoek
The aim of the study is to show the effectiveness of tailored cognitive-behavioral E-health care for risk groups of patients with rheumatoid arthritis in comparison to usual care.
Onderzoeksopzet
For the treatment group, assessments take place before and after treatment and at the follow-up measurements 3, 6, 9 and 12 months post treatment. For the control group, assessments take place at 0, 6, 9, 12, 15 and 18 months.
Onderzoeksproduct en/of interventie
The intervention of E-health tailored cognitive-behavioral therapy consists of tailored individual treatments with E-health treatment modules that target the most frequently experienced problems which rheumatoid arthritis patients have to cope with: pain and functional disability, fatigue, negative mood and social relationships. Choice of E-health treatment modules are determined on the basis of patient priorities and therapist judgments. All E-health treatments modules consist of cognitive and behavioral interventions with homework assignments of about half hour per day. In all treatments modules, the final booster session deal with relapse prevention and further improvement of the attained goals. For the E-health application, patients have at least once a week mail contact with the therapist.
Patients in the control group will receive standard rheumatology care without E-health or face-to-face applications of tailord cognitive-behavioral care.
Algemeen / deelnemers
PO Box 9555
A.W.M. Evers
Leiden 2300 RB
The Netherlands
+31 (0)71 527 3627
a.evers@fsw.leidenuniv.nl
Wetenschappers
PO Box 9555
A.W.M. Evers
Leiden 2300 RB
The Netherlands
+31 (0)71 527 3627
a.evers@fsw.leidenuniv.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. ACR diagnosis rheumatoid arthritis;
2. Age above 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy;
2. Severe physical and/or psychiatric comorbidity that interfere with the study procotol;
3. Illiteracy;
4. Current psychological treatments.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1983 |
| NTR-old | NTR2100 |
| Ander register | ZonMw : 170992803 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |