Condition category
Musculoskeletal Diseases
Date applied
21/03/2017
Date assigned
27/03/2017
Last edited
27/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Rheumatoid arthritis (RA) is a long-term condition that causes pain, swelling and stiffness in the joints. Patients with RA experience pain, fatigue, and limitations in daily activities and participation. Apart from the consequences of the disease, patients with RA deal with different treatments and a variety of healthcare providers during the course of their illness. Therefore, supporting RA patients in self-managing their disease is important. One strategy to enhance self-management is the use of an interactive care booklet. A care booklet can provide patients with information on their disease, treatment options and what they can do for themselves. Additionally, it includes tools for monitoring symptoms, preparing for consultations, and recording treatment targets and medication. Although the use of a care booklet can be beneficial, not a lot of patients use a care booklet. However, little is known about the best strategies to introduce a care booklet to patients. Therefore the aim of this study is to compare two different distribution strategies: unsolicited supply (unsolicited mailing of the care booklet free of charge to the home-address of patients) and supply on demand (mailing a letter about the care booklet to the home address of patients with the option to order the booklet free of charge by sending back a reply card).

Who can participate?
Patients aged 18 and over with rheumatoid arthritis who have a future scheduled visit with a rheumatologist in one of the participating hospitals

What does the study involve?
Participants are randomly allocated to be sent the care booklet (unsolicited supply) or to be sent an information letter with the option to order the care booklet (supply on demand). Participants can choose for themselves if they want to order and/or use the care booklet. Four months later, some of the participants are sent a questionnaire asking whether they have used the care booklet in the past 4 months.

What are the possible benefits and risks of participating?
There are no direct benefits or risks to those taking part. Receiving the care booklet for free can be seen as a benefit.

Where is the study run from?
1. Sint Maartenskliniek Hospital (Netherlands)
2. Leids University Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
September 2013 to June 2014

Who is funding the study?
The Dutch Arthritis Foundation (Reumafonds) (Netherlands)

Who is the main contact?
1. Miss Aniek Claassen
2. Dr Cornelia van den Ende

Trial website

Contact information

Type

Scientific

Primary contact

Miss Aniek Claassen

ORCID ID

Contact details

PO Box 9011
Nijmegen
6500 GM
Netherlands

Type

Scientific

Additional contact

Dr Cornelia van den Ende

ORCID ID

Contact details

PO Box 9011
Nijmegen
6500 GM
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

676-RA-ZORGWIJZER

Study information

Scientific title

The use of an interactive self-management care booklet by patients with rheumatoid arthritis: a multicenter, randomised comparison of two distribution strategies

Acronym

ZORGWIJZER RA

Study hypothesis

It is hypothesized that the method of distribution of a care-booklet, unsolicited supply (i.e. sending a care-booklet without being requested) versus supply on demand (i.e. offering the option to order a care booklet), affects the use of the care-booklet. Patients who are offered the option to order a care booklet are expected to be better motivated to use this care booklet than patients who receive the care booklet unsolicited.

Ethics approval

The Institutional Review Board of the University Medical Centre, Nijmegen (11/07/2013, ref: 2013/292) and the Medical Ethics Review Committee of the University Medical Centre, Leiden (07/11/2013, ref: P13.202), The Netherlands, both reviewed the study protocol. An exemption was obtained, as ethical approval for this type of study is not required under Dutch law.

Study design

Multicenter randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Rheumatoid arthritis

Intervention

A care booklet for patients with RA was developed. The RA care booklet is a patient-held booklet with information about RA, living with RA and self-management of RA. It covers the following topics: symptoms and complaints, general health, medication, healthcare providers, daily activities, work, leisure time and environment. With respect to self-management the following questions are included: “what do I want to achieve?”, “what can I do?”, “how can I stay physically active?”, “how can I take it easy on myself?” and, “what do I would like to discuss with healthcare providers?”. The care booklet also incorporates a separate booklet, the RA care pass (‘zorgpas RA’), where patients can describe personal information about their medical history, medication use, healthcare providers, results of laboratory and physical examinations (i.e. Disease Activity Score (DAS28-Score)), complaints and symptoms, treatment goals and preparing for an appointment with the healthcare provider.

Participants are randomised to one of two distribution strategies:
1. Unsolicited mailing of the care booklet free of charge to the home-address of patients accompanied by an introductory letter on behalf of the medical head of the Department of Rheumatology
2. Distribution on demand: mailing an introductory letter about the care booklet on behalf of the medical head of the Department of Rheumatology to the home-address of patients with the option to order the booklet and pass free of charge. Patients can order the RA care booklet and care pass by sending back a reply card.

Participants are assessed at a single time endpoint 4 month after baseline. Patients are asked whether they used the care booklet in the past 4 months. Answer-options include: “no”, “yes, I read (parts of) the care booklet”, “yes, I made notes in the care pass”, “yes, I discussed (parts of) the care booklet/pass with my healthcare provider”, “yes, I used the care booklet in a different way, namely….”. Multiple answers are possible. Patients who answer “no”, or state that they did not receive or order the care booklet are classified as “non-users”. Patients answering 1 or more of the “yes” answers are classified as “users”.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Self-reported use of the RA care booklet, assessed using a questionnaire at 4 months follow-up

Secondary outcome measures

Assessed using a questionnaire at 4-months follow-up:
1. Clinical characteristics including disease duration (years since diagnosis) and medication use (NSAIDs, corticosteroids, DMARDs, biologicals, other)
2. Disease activity, measured using the Rheumatoid Arthritis Disease Activity Index (RADAI)
3. Limitations in activities, measured using the Health Assessment Questionnaire Disability Index
4. Self-efficacy, measured using the Dutch General Self-efficacy Scale
5. Illness perceptions, measured using the Revised Illness Perception Questionnaire
6. Educational needs, measured using the Dutch version of the Educational Needs Assessment Tool

Overall trial start date

01/09/2013

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with RA
2. Aged ≥18 years old
3. Having a future scheduled visit with a rheumatologist

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

372

Participant exclusion criteria

Patients from the LUMC hospital who are participating in another ongoing study

Recruitment start date

01/09/2013

Recruitment end date

01/02/2014

Locations

Countries of recruitment

Netherlands

Trial participating centre

Sint Maartenskliniek Hospital
Hengstdal 3
Ubbergen (Nijmegen)
6574 NA
Netherlands

Sponsor information

Organisation

Sint Maartenskliniek

Sponsor details

PO Box 9011
Nijmegen
6500 GM
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Reumafonds

Alternative name(s)

Dutch Arthritis Foundation, DAF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Cornelia van den Ende

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

27/03/2017: Participant information sheet uploaded.