Condition category
Nervous System Diseases
Date applied
31/03/2008
Date assigned
30/04/2008
Last edited
07/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alessandra Solari

ORCID ID

Contact details

Unit of Neuroepidemiology
Foundation IRCCS Neurological Institute “C.Besta”
Via Celoria
11
Milan
20133
Italy
+39 (0)2 2394 2391
solari@istituto-besta.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007/R/19

Study information

Scientific title

Acronym

SIMS-Trial

Study hypothesis

To assess the effectiveness, in terms of patient knowledge and satisfaction with the information received, of a structured add-on information interview, given within 15 days of communicating a diagnosis of multiple sclerosis (MS).

Ethics approval

Neurological Institute "C. Besta" Foundation IRCCS Ethics Committee, 18/12/2007, ref: 9/2007

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Multiple sclerosis (MS)

Intervention

At least 120 patients will be recruited from eight Italian centres and randomly assigned to receive the study intervention (add-on information aids, n = 60) or control (no add-on information aids, n = 60).

The add-on interview is conducted by trained neurologists (approximately one hour in length), during which information about MS is presented with the aid of a specifically designed compact disc (CD). The information is tailored to individual needs; the patient is also given a booklet containing all the information provided.

The "Sapere Migliora" CD:
"Sapere Migliora" can be approximately rendered as "knowledge helps"; it works in Italian because the initials of the condition are SM – sclerosi multipla. The CD contains an introduction followed by a menu of the headings:
1. MS insights:
1.1. Central nervous system
1.2. The myelin and the axon
1.3. Myelin and axon's damage
1.4. Mechanisms of damage
2. The diagnosis:
2.1. Relapses
2.2. Most common symptoms at disease onset
2.3. Clinical examination
2.4. Laboratory examinations
3. What happens after diagnosis:
3.1. MS course
3.2. Scheduled visits
4. Therapies:
4.1. Research at basis of therapies
4.2. Treatment for relapses
4.3. Disease-modifying drugs
5. Emotions:
5.1. Common emotional reactions
5.2. Reactions due to neurological damage
5.3. Depression
6. Having a child:
6.1. Motherhood
6.2. Fatherhood
7. Frequently asked questions (FAQs):
7.1. General questions
7.2. Questions on pregnancy
8. Glossary

Animations and intuitively-obvious aids are used extensively throughout the CD. A voice in the background illustrates the entire presentation. Emotions are also presented as a movie lasting eight minutes.

At the beginning of the interview, the "Sapere Migliora" CD is started and an opening menu appears. The patient indicates to the "informing neurologist" at which point on the program he/she wants to start. The "informing neurologist" navigates through the program guided by the patient's preferences, spending as much time as needed on each topic, skipping parts that the patient shows little interest in; opportunity is provided to repeat the exposition of topics and discuss them. Links to the glossary are present from all pertinent points on the program. Patients are encouraged to ask questions. The path through the CD during the session is traced electronically, and time spent on each topic is recorded, for subsequent analysis. At the end of the interview the patient is given the take-home booklet.

At each centre there will be an "informing neurologist" trained to conduct the add-on interview. It is desirable that the referring neurologist is always the same for each patient; however, in large centres working in a team a single patient can be followed by more than one referring physician.

The "Sapere Migliora" Booklet:
The "Sapere Migliora" take-home booklet (A5 148 x 210 mm notepad format) has eight chapters (90 pages), a glossary (36 pages), and a section for the patient's notes. The first seven chapters match the CD topics in title and information provided. Chapter eight (Communicating the MS diagnosis: experiences of patients and health professionals) reports findings from our preliminary study. At the end of each chapter a small number of references/links are given, selected from the most comprehensive and up-to-date material available, many in Italian but some in English.

Total duration of follow-up: six months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary endpoints, assessed one and six months after diagnosis disclosure, are knowledge and satisfaction with diagnosis communication as determined by the MS Knowledge Questionnaire (MSKQ) and the instrument "Comunicazione medico-paziente nella Sclerosi Multipla" (revised) (CoSM-R):
1. MSKQ: no widely-accepted measure of patient knowledge on MS is currently available. The MSKQ, specifically devised for this study, consists of 25 multiple-choice items, is self-administered, and designed to be applicable to a wide range of people with MS. The total score is the number of correct responses (range 0 - 25).
2. CoSM-R: this MS-specific scale was recently devised for this study. CoSM-R is self-administered and consists of multiple-choice questions about the moment of MS diagnosis communication (9 items), and about the period immediately following diagnosis communication (16 items).

Secondary outcome measures

Secondary endpoints are changes at one and six months in:
1. The Hospital Anxiety and Depression Scale (HADS)
2. The Control Preference Scale (CPS). The CPS was translated and cross-culturally adapted into Italian from the original English version.

Other endpoints measured over the study period:
3. Attrition
4. Number of consultations
5. Number of visits to the MS centre

Overall trial start date

18/03/2008

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects are eligible for recruitment if all the following criteria are satisfied:
1. Diagnostic workup to confirm/exclude MS diagnosis
2. Age 18 years and above, either sex
3. Signed informed consent (pre-diagnostically)

Consenting subjects will be randomised at the end of the diagnostic workup, provided that all the following criteria apply:
1. Diagnosis of MS confirmed
2. Interval between informed consent and MS diagnosis within seven months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 120 patients (intervention n = 60 or control n = 60)

Participant exclusion criteria

Subjects will be excluded from the study if one or more of the following criteria apply:
1. Previous MS diagnosis
2. Presence of definite cognitive compromise, psychiatric disease, or substance abuse

Recruitment start date

18/03/2008

Recruitment end date

31/03/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Unit of Neuroepidemiology
Milan
20133
Italy

Sponsor information

Organisation

Neurological Institute "C. Besta" Foundation IRCCS (Italy)

Sponsor details

Unit of Neuroepidemiology
Via Celoria
11
Milan
20133
Italy
+39 (0)2 2394 2391
solari@istituto-besta.it

Sponsor type

Hospital/treatment centre

Website

http://www.istituto-besta.it

Funders

Funder type

Research organisation

Funder name

The Italian Multiple Sclerosis Society (Italy)

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20858692
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22040528
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21621796
2014 qualitative study results in: http://www.ncbi.nlm.nih.gov/pubmed/22040528

Publication citations

  1. Results

    Solari A, Martinelli V, Trojano M, Lugaresi A, Granella F, Giordano A, Messmer Uccelli M, D'Alessandro R, Pucci E, Confalonieri P, Borreani C, , An information aid for newly diagnosed multiple sclerosis patients improves disease knowledge and satisfaction with care., Mult. Scler., 2010, 16, 11, 1393-1405, doi: 10.1177/1352458510380417.

  2. Results

    Borreani C, Giordano A, Falautano M, Lugaresi A, Martinelli V, Granella F, Tortorella C, Plasmati I, Radaelli M, Farina D, Dalla Bella E, Bianchi E, Acquarone N, Miccinesi G, Solari A, , Experience of an information aid for newly diagnosed multiple sclerosis patients: a qualitative study on the SIMS-Trial., Health Expect, 2014, 17, 1, 36-48, doi: 10.1111/j.1369-7625.2011.00736.x.

  3. Results

    Giordano A, Granella F, Lugaresi A, Martinelli V, Trojano M, Confalonieri P, Radice D, Solari A, , Anxiety and depression in multiple sclerosis patients around diagnosis., J. Neurol. Sci., 2011, 307, 1-2, 86-91, doi: 10.1016/j.jns.2011.05.008.

  4. Qualitative study results

    Borreani C, Giordano A, Falautano M, Lugaresi A, Martinelli V, Granella F, Tortorella C, Plasmati I, Radaelli M, Farina D, Dalla Bella E, Bianchi E, Acquarone N, Miccinesi G, Solari A, , Experience of an information aid for newly diagnosed multiple sclerosis patients: a qualitative study on the SIMS-Trial., Health Expect, 2014, 17, 1, 36-48, doi: 10.1111/j.1369-7625.2011.00736.x.

Additional files

Editorial Notes