Implementation of the Sapere Migliora Information aid for newly diagnosed multiple sclerosis (MS) patients in routine clinical Practice (SIMS-Practice)

Implementation of the Sapere Migliora Information aid for newly diagnosed multiple sclerosis (MS) patients in routine clinical Practice (SIMS-Practice): a phase IV open-label trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78940214

Enrollment

152

Registered

2012-09-04

Start date

2012-05-03

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis

Interventions

The Sapere Migliora IA used in the SIMS-Trial (ISRCTN81072971) consisted of a personal interview with a navigable CD, and a take-home booklet which was given to the patient at the end of the interview

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. MS diagnosis (Polman 2011 criteria) 2. MS diagnosis disclosed =18 years 4. Written informed consent

Exclusion criteria

Exclusion criteria: Primary progressive MS course

Design outcomes

Primary

Measure	Time frame
1. The MSKQ is a self-administered general MS knowledge questionnaire consisting of 25 multiple-choice items; it is available in two versions (A and B) differing in order of item presentation; version A will be used in the present study. Total score is the number of correct responses (range 0-25). A French for France version of the MSKQ has been recently produced by the Mapi Institute. 2. The COSM-R (Comunicazione medico-paziente nella Sclerosi Multipla-revised version) is a self-administered multiple-choice questionnaire assessing satisfaction regarding the moment of MS diagnosis communication (section 1, 5 items; not an endpoint of the present study) and the ensuing period (section 2, 15 items). Five additional items do not contribute to the score but record diagnosis disclosure date, who communicated it, and whether additional information and second opinions were sought. 3. Measures taken to minimize/avoid bias (Surveys A and B): Two weeks after the expected return date, patients who do not send back the postal questionnaires will be sent a reminder (and new questionnaire, if required) by the coordinating unit. General characteristics of non-responders will be compared with those of responders.	—

Measure

Time frame

1. The MSKQ is a self-administered general MS knowledge questionnaire consisting of 25 multiple-choice items; it is available in two versions (A and B) differing in order of item presentation; version A will be used in the present study. Total score is the number of correct responses (range 0-25). A French for France version of the MSKQ has been recently produced by the Mapi Institute. 2. The COSM-R (Comunicazione medico-paziente nella Sclerosi Multipla-revised version) is a self-administered multiple-choice questionnaire assessing satisfaction regarding the moment of MS diagnosis communication (section 1, 5 items; not an endpoint of the present study) and the ensuing period (section 2, 15 items). Five additional items do not contribute to the score but record diagnosis disclosure date, who communicated it, and whether additional information and second opinions were sought. 3. Measures taken to minimize/avoid bias (Surveys A and B): Two weeks after the expected return date, patients who do not send back the postal questionnaires will be sent a reminder (and new questionnaire, if required) by the coordinating unit. General characteristics of non-responders will be compared with those of responders.

—

Secondary

Measure	Time frame
1. The HADS is a self-assessed questionnaire consisting of 14 multiple-choice (0-3 Likert scale) items probing symptoms of anxiety (7 items) and depression (7 items). HADS anxiety (HADS-A) and depression (HADS-D) scores range from 0 (no symptoms) to 21 (most severe symptoms) 2. Patient's socio-demographic data, and his/her satisfaction with the information aid will be recorded on Questionnaire 4 3. Clinical information will be obtained from the case report form	—

Measure

Time frame

1. The HADS is a self-assessed questionnaire consisting of 14 multiple-choice (0-3 Likert scale) items probing symptoms of anxiety (7 items) and depression (7 items). HADS anxiety (HADS-A) and depression (HADS-D) scores range from 0 (no symptoms) to 21 (most severe symptoms) 2. Patient's socio-demographic data, and his/her satisfaction with the information aid will be recorded on Questionnaire 4 3. Clinical information will be obtained from the case report form

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026