Condition category
Musculoskeletal Diseases
Date applied
31/05/2011
Date assigned
21/06/2011
Last edited
03/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Inflammatory rheumatic diseases represent a major burden to the individual patient and to the society. Rheumatic diseases are characterized by inflammatory processes that may lead to joint damage and various degrees of disability. Current treatment focuses on early diagnosis and early use of medication that improves the disease. However, a major proportion of patients has remaining disability and does still need rehabilitation. Several studies have shown that patients with rheumatic diseases benefit from rehabilitation, but the effect seems to fade over time, and most patients are back to their initial health status six to twelve months after discharge from rehabilitation. A major challenge is therefore to help patients maintain self-management strategies introduced in the rehabilitation period, and thereby enhance a longer lasting effect of rehabilitation.

Goal planning or goal setting is considered an important part of rehabilitation practice. Several studies show that goal planning can influence patients' adherence to treatment regimes and improve immediate patient performance, but evidence regarding how it may improve results after rehabilitation programmes is inconsistent. Rehabilitation goals often address life style changes which involve a process over some time before settled as a new habit. This process involves both mental and behavioural elements, and may by the end of a rehabilitation stay still be unclear and fragile.

Telephone follow-up to support individualized goals and action plans has been reported to increase the effect of a rehabilitation program compared to control groups receiving more general health screening topics or no telephone calls at all. A tailored patient follow-up program as an extension to the rehabilitation stay may therefore prevent fading of the achieved results.

The objective of goal setting involves a change in patient behaviour. Theories of behaviour and behaviour change may therefore guide goal setting interventions. Motivational interviewing is a strategy based on cognitive behavioural theory, and is designed to motivate and prepare people for behaviour change. Several studies conclude that the use of cognitive behavioural approaches in exercise programs and other self-management interventions increase their effectiveness in patients with rheumatic diseases, and a recent review concluded that common features of effective self-management programs where that they included explicit use of cognitive behavioural therapy, individualized weekly action plans with progress review, that they had written records of agreements made between patients and health worker (protocols) with participant hand-books, and that they were lead by the same trained leaders.

Based on previous described research and professional agreement between health workers at different rheumatology departments in the South-East of Norway, a new and potentially more effective rehabilitation program has been developed.

The main aim of this study is to measure and decide the usefulness of this new rehabilitation program (the PRAISE-program) compared to the current traditional rehabilitation programmes. The expected usefulness of the new program will be expressed in terms of goal attainment and health benefits for participating patients, and with regard to if it saves money compared to the costs involved.

Who can participate?
Patients who are admitted to the participating rehabilitation units with one of the following inflammatory rheumatic diagnoses: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus and juvenile idiopathic arthritis. In addition patients with generalized arthritis with affection of either hip or knee can take part in the study.

To take part you need to be:
1. Aged 18 years or older
2. Have a good understanding of Norwegian language

Patients with mental dysfunction or severe psychiatric disorder, and patients with rheumatic diseases undergoing rehabilitation after orthopedic surgery can not participate in the study.

Patients will be recruited through information from health professionals at the participating centers at admission to the rehabilitation stay and those who are interested will receive written information about the study. To enrol, participants will have to give their informed consent.

What does the study involve?
The new program (PRAISE-program) is based on existing rehabilitation programs delivered at different rheumatology departments and rehabilitation centres in the South-East of Norway, but the following four elements have been added:
1. A structured goal-setting and evaluation process during the rehabilitation stay, including deciding of goals to proceed with in the patient's home-setting after discharge
2. A self-help booklet for use under and after the rehabilitation stay
3. A follow-up program consisting of four phone-calls from a health care provider at the hospital, directed at goal attainment and motivation for continued effort
4. Organized and thorough use of motivational interviewing in the goal setting and evaluation process, as well as in the follow-up phone calls. Motivational interviewing is a form of conversation aimed at preparing people for change

While one group will receive the PRAISE program, the other group will receive traditional rehabilitation with no other support after discharge than what is usually provided (treatment as usual). Both groups will receive medical treatment as usual.

What are the possible benefits and risks of participating?
There are no known risks to participants.

All participants, including controls, will receive rehabilitation which may improve their health and physical function.

Participants randomized to the intervention group will additionally receive a structured, individualized goal setting program, a self.help-booklet and a follow-up program consisting of four phone calls from health care providers located at the different hospitals and rehabilitation centres. The phone call follow-up will be directed at pursuing individual goal attainment and enhance motivation for continued effort. All these elements are expected to increase the health benefits of their rehabilitation stay.

Where is the study run from?
The study takes place at various rheumatological rehabilitation departments at hospitals and a rehabilitation center in the South-East of Norway, with a total of six departments/centres participating in the enrolment.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between August 2011 and June 2012. Follow-up examinations will continue towards July 2013.

Who is funding the study?
Health Region South-East of Norway

Who is the main contact?
Dr Ingvild Kjeken (Senior researcher)
National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital, P.O. Box 23 Vinderen
N-0319 Norway
Tel: +47 45 48 45 / +47 98 80 26 14
E-mail-address: ingvild.kjeken@diakonsyk.no

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Ingvild Kjeken

ORCID ID

Contact details

The National Resource Center for Rehabilitation in Rheumatology (NRRK)
Diakonhjemmet Hospital
Pb 23 Vinderen
Oslo
0319
Norway
+47 (0)22 45 48 45
ingvild.kjeken@diakonsyk.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of structured goal planning and tailored follow-up in rehabilitation for patients with inflammatory rheumatic diseases: A stepped wedge cluster randomised trial

Acronym

PRAISE

Study hypothesis

The main objective of this trial is to evaluate goal attainment, health effects and cost effectiveness of the new rehabilitation program (PRAISE) compared to the current traditional rehabilitation programs.

On 24/02/2014 the anticipated end date was changed from 15/06/2012 to 30/06/2013.

Ethics approval

1. Norwegian Regional Committee for Medical Research Ethics Health Region South-East approved on 19/05/2011, ref: 2011/909
2. The Privacy Protection representative at Oslo University Hospital approved on 31/03/2011, ref: 2011/6602

Study design

Interventional multicentre stepped wedge cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Inflammatory rheumatic diseases / rehabilitation

Intervention

The new program (PRAISE) is based on existing rehabilitation programs delivered at rheumatology departments and rehabilitation centres in Health Region Sout-East Norway, but the following four elements have been added:
1. A structured goal-setting and evaluation process during the rehabilitation stay, including deciding of goals to proceed with in their home-setting after discharge
2. A self-help booklet for use under and after the rehabilitation stay
3. A follow-up program consisting of four phone-calls from health care provider at the hospital directed at goal attainment and motivation for continued effort
4. Systematic use of motivational interviewing in the goal setting and evaluation process, as well as in the follow-up phone calls

The control group will receive traditional rehabilitation with no other support after discharge than what is usually provided (treatment as usual).

Both groups will receive medical treatment as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Goal attainment and health related quality of life measured by the Patient Generated Index (PGI).

PGI is an individualised instrument which is completed in three stages:
1.1. In stage one the respondent is asked to identify up to five important areas of their life that are affected by their rheumatic disease.
1.2. In stage two the respondents is asked to rate these areas on a numeric rating scale from 0 - 6 where 0 = as bad as could possibly be, and 6 = as good as could possibly be.
1.3. In stage three, respondents are asked to distribute ten points to indicate the relative importance of each of the areas described in stage one, with most points allocated to the most important areas.

The PGI may thereafter serve as a basis for developing individual rahabilitation goals, and the scores and re-scorings to evaluate attainment of these goals.

Secondary outcome measures

1. The Arthritis Self-Efficacy Scales (ASES) for pain and symptoms
2. Pain and fatigue measured on Numeric Rating Scales (NRS)
3. Other aspects of health related quality of life measured by the SF-36 domains Bodily Pain (BP), Role Physical (RP), Mental Health (MH), Vitality (VT), General Health (GH), Role Emotional (RE) and Social Functioning (SF).
4. In addition data on health care resource allocation and costs will be collected
The data will be collected at baseline, discharge and follow-up at 26 weeks and 52 weeks after discharge.

Overall trial start date

23/08/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients admitted to the participating rehabilitation centres with one of the following inflammatory rheumatic diagnoses: rheumatoid arthritis, psoriatric arthritis, ankylosing spondylitis, systemic lupus erythematosus, juvenile idiopathic arthritis or generalised osteoarthritis effecting either the hip or knee
2. Aged 18 years or older
3. A good understanding of Norwegian language
4. Able and willing to sign the informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A total of 312 patients will be recruited into the study

Participant exclusion criteria

1. Cognitive impairment
2. Severe psychiatric disorder
3. Patients with rheumatic disease undergoing rehabilitation after elective orthopaedic surgery

Recruitment start date

23/08/2011

Recruitment end date

30/06/2013

Locations

Countries of recruitment

Norway

Trial participating centre

The National Resource Center for Rehabilitation in Rheumatology (NRRK)
Oslo
0319
Norway

Sponsor information

Organisation

Diakonhjemmet Hospital (Norway)

Sponsor details

Pb 23 Vinderen
Oslo
0319
Norway
k.b.hagen@medisin.uio.no

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Health Region South/East (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24886382

Publication citations

  1. Protocol

    Kjeken I, Berdal G, Bø I, Dager T, Dingsør A, Hagfors J, Hamnes B, Eppeland SG, Fjerstad E, Mowinckel P, Nielsen M, Rørstad RW, Sand-Svartrud AL, Slungaard B, Wigers SH, Hagen KB, Evaluation of a structured goal planning and tailored follow-up programme in rehabilitation for patients with rheumatic diseases: protocol for a pragmatic, stepped-wedge cluster randomized trial., BMC Musculoskelet Disord, 2014, 15, 153, doi: 10.1186/1471-2474-15-153.

Additional files

Editorial Notes