Tailored cognitive-behavioral E-health care in patients with rheumatoid arthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28299

Enrollment

130

Registered

2009-11-09

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Reumatoïde artritis

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. ACR diagnosis rheumatoid arthritis; 2. Age above 18 years.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Severe physical and/or psychiatric comorbidity that interfere with the study procotol; 3. Illiteracy; 4. Current psychological treatments.

Design outcomes

Primary

Measure	Time frame
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. The primary outcome measures are measured as follows: 1. Impact on physical functioning: composite z-scores of A. Pain (IRGL, Huiskes, 1990); B. Fatigue (CIS, Vercoulen, 1996). 2. Impact on psychological functioning: composite z-scores of: A. Negative mood (IRGL, Huiskes, 1990); B. Anxiety (IRGL, Huiskes, 1990); C. Depression (BDI, Beck, 1988). 3. Impact on daily activities: composite z-scores of A. Mobility and self-care (IRGL, Huiskes, 1990); B. Role limitations due to emotional and physical health problems (SF-36. Ware, 1993).	—

Measure

Time frame

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. The primary outcome measures are measured as follows: 1. Impact on physical functioning: composite z-scores of A. Pain (IRGL, Huiskes, 1990); B. Fatigue (CIS, Vercoulen, 1996). 2. Impact on psychological functioning: composite z-scores of: A. Negative mood (IRGL, Huiskes, 1990); B. Anxiety (IRGL, Huiskes, 1990); C. Depression (BDI, Beck, 1988). 3. Impact on daily activities: composite z-scores of A. Mobility and self-care (IRGL, Huiskes, 1990); B. Role limitations due to emotional and physical health problems (SF-36. Ware, 1993).

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Secondary

Measure	Time frame
Secondary outcomes include cost-effectiveness analyses and effects on disease severity and treatment compliance with regard to standard rheumatological care.	—

Contacts

Public ContactA.W.M. Evers

LUMC PO Box 9555

a.evers@fsw.leidenuniv.nl+31 (0)71 527 3627

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)