Effectiveness of a Structured Information interview in people with newly-diagnosed Multiple Sclerosis

Conditions

Multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis

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, SIMS-Trial group.

2011-11-0112 citations

10.1111/j.1369-7625.2011.00736.x

Anxiety and depression in multiple sclerosis patients around diagnosis.

Giordano A, Granella F, Lugaresi A, Martinelli V, Trojano M, Confalonieri P, Radice D, Solari A, SIMS-Trial group.

2011-05-3179 citations

10.1016/j.jns.2011.05.008

An information aid for newly diagnosed multiple sclerosis patients improves disease knowledge and satisfaction with care.

Solari A, Martinelli V, Trojano M, Lugaresi A, Granella F, Giordano A, Messmer Uccelli M, D'Alessandro R, Pucci E, Confalonieri P, Borreani C, SIMS-Trial group.

2010-09-2152 citations

10.1177/1352458510380417

Interventions

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 =

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed