|- candidate number||20830|
|- NTR Number||NTR4871|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-okt-2014|
|- Secondary IDs||2014-1208 CMO|
|- Public Title||Het ontwikkelen en testen van een online ondersteuningsprogramma voor Reumatoide Artritis patiŽnten |
|- Scientific Title||Development and early testing of an online self-management program for Rheumatoid Arthritis patients |
|- ACRONYM||Reuma zelf te lijf|
|- hypothesis||The aim of the pilot trial is to: |
1. evaluate the potential effectiveness and effect size of the online self-management program for Rheumatoid Arthritis patients
2. to identify outcome measures most likely to capture potential patient benefit;
3. to evaluate continued participation or dropping out of the online self-management program.
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||- RA Patients;|
- an age of 18 years or older;
- the ability to speak and read the Dutch language;
- the availability of a computer.
|- Exclusion criteria||- Patients receiving psychiatric treatment|
- Patients receiving the psychological treatment Cognitive Behavior Therapy or other therapy related to their RA disease
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||28-nov-2014|
|- planned closingdate|
|- Target number of participants||200|
|- Interventions||All participants in the study receive usual care containing regular visits to a rheumatologist
and a specialized nurse from whom they receive medical treatment, advice and information
about their disease and socio-psychological aspects. RA patients receive this care in a
In addition to the care as usual, participants in the treatment group will receive the e-health
intervention. The intervention consists of nine modules:1) Finding balance between rest and
activity, 2) Setting boundaries, 3) Communication with professionals, 4) Coping with assistive
devices and home and household products, 5) Medication intake, 6) Coping with worries, 7)
Coping with RA, and 8) Coping with social support, 9) Performing physical activities.
Strategies to support the behavioural change and behavioural maintenance of selfmanagement
behaviour are: 1) providing information to increase patientsí knowledge, 2)
creating awareness by making assignments, 3) persuasive communication to change the
attitude of patients, 4) modelling through videoís and texts to increase patientsí self-efficacy,
5) social comparison through videoís and texts to increase patientsí self-efficacy, 6)
reinterpreting emotional and somatic state by texts to increase self-efficacy, 7) feedback and
planning coping response by text messages to maintain changed behaviour and 8) selfevaluation
through past temporal comparisons to maintain changed behaviour.
|- Primary outcome||We will use the following questionnaires:
The Patients Activation Measure (PAM-13) to measure self-management
The RAND-36 to measure health related quality of life
The Modified Pain Coping Inventory for Fatigue (MPCI-F) to measure coping with fatigue
The Rheumatoid Arthritis Self-Efficacy Scale (RASE) to measure task specific Self-efficacy
The Patient Efficacy in Patient-Physician Interactions (PEPPI-5) to measure patients'efficacy in obtaining medical information and attention to their medical concerns from physicians.
The Self-Management Ability Scale Short Form (SMAS-S) to measure self-management skills in relation to welfare.
NRS pain and NRS fatigue to measure the level of pain and fatigue of patients
|- Secondary outcome||The process evaluation of the e-health self-management program will be on actual use,
added value of the e-health intervention, and dropping out of the e-health intervention. Both patients and their healthcare professionals will take part in the evaluation. Qualitative data on the feasibility of the e-health self-management program will be obtained via semi-structured interviews. The patients will be interviewed about their experience using the intervention asking questions on worthiness, time consumption and relevance. The actual use of the ehealth
self-management program will be monitored quantitatively during the intervention period counting data on frequency of the patientsí visits to the e health self-management program.
Further, we will assess the usability of the program with questions about the texts, excercises, log-in and the design of the program, based on a questionnaire which was earlier used in the studies supervisod by Andrea Evers.
|- Timepoints||Baseline data collection will start in December 2014. Repeated measures will be executed at six months and 12 months when the intervention is finished, again by filling out the questionnaire. The estimated time to fill out the questionnaire is 30 to 45 minutes. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||MSc. R.M. Zuidema|
|- CONTACT for SCIENTIFIC QUERIES||MSc. R.M. Zuidema|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Roche|
|- Brief summary||Rationale: Rheumatoid Arthritis (RA) is a chronic inflammatory and systemic disease, which predominantly affects the joints. RA occurs in 0.5-1.0% of the adult population worldwide and two to four times more in women than in men. In the Netherlands approximately 150.000 people suffer from RA, making it the most common inflammatory joint disease. Because of
the large impact of RA on health status and healthcare expenditures, there is a growing interest in self-management for RA patients. However, while traditional delivery of selfmanagement support is effective overall, several problems in the development of e-delivered programs have led to variations in their effectiveness.|
Objective: 1) To evaluate the potential effectiveness and effect size of the e-health selfmanagement support program for patients with RA. 2) To identify outcome measures most likely to capture potential patient benefit. 3) To evaluate continued participation or dropping out of the e-health intervention.
Study design: The intervention will be tested in an early randomized controlled trial with a six and twelve month follow-up from baseline.
Study population: Patients with RA and their healthcare professionals at the outpatient clinic of two hospitals in the Netherlands.
Intervention: On top of usual care the treatment group will receive a e-health selfmanagement program. The intervention consists of nine modules and strategies to support the behavioural change and behavioural maintenance of self-management behaviour.
Outcome: We will measure self-management behaviour (PAM-13), quality of life (RAND-36),
self-management skills (SMAS-S), coping with fatigue (using MPCIF),
Self-Efficacy (PEPPI-5 and RASE), pain and fatigue (NRS)
|- Main changes (audit trail)||31-mei-2015: Changes:
New: -Patients receiving psychiatric and
psychological treatment will be excluded.
New:The process evaluation of the e-health
self-management program will be on
actual use, added value of the e-health
intervention, and dropping out of the e-
health intervention. Both patients and
their healthcare professionals will take
part in the evaluation. Qualitative data on
the feasibility of the e-health self-
management program will be obtained via
semi-structured interviews. The patients
will be interviewed about their experience
using the intervention asking questions on
worthiness, time consumption and
relevance. The actual use of the ehealth
self-management program will be
monitored quantitatively during the
intervention period counting data on
frequency of the patientsí visits to the e
health self-management program.
|- RECORD||29-okt-2014 - 31-mei-2015|