TELESM-edu.Nursing: a Personalised Nursing Intervention for People With Multiple Sclerosis

Official title

TELESM-edu.Nursing: Efficacy of a Personalised Nursing Intervention for the Management of People With Multiple Sclerosis

Overview

The primary aim of this study is to evaluate the impact of the telenursing intervention "TELESM-edu.nursing" on people with Multiple Sclerosis (pwMS), specifically focusing on their navigational capacity within the healthcare system (Navigation Health Literacy) and their perceived level of Health Literacy. The study will also assess the effectiveness of the intervention in improving patient satisfaction with current therapy, patients' beliefs and attitudes towards the prescribed therapeutic regimen, satisfaction of informational needs, trust in nurses, and degree of disability. The secondary objective is to evaluate the feasibility and sustainability of a personalised telenursing programme for pwMS. Feasibility will be assessed based on: (I) the ability to recruit and retain participants, measured through adherence rates and dropout rates in the intervention group; (II) participants' acceptability, usability, and satisfaction with the intervention; and (III) healthcare staff satisfaction and perceived usability of the intervention. The main research questions addressed in this study are: Does the "TELESM-edu.nursing" intervention improve patients' Navigation Health Literacy and overall Health Literacy levels? Does the intervention improve patient satisfaction with therapy and fulfilment of informational needs? Does the intervention positively influence patients' beliefs and attitudes towards their treatment? Does the intervention increase trust in nurses? What is the impact of the intervention on patients' level of disability? Is the telenursing programme feasible, acceptable, and sustainable for both patients and healthcare professionals? Both study groups will receive the standard in-person informational and educational programme, as well as routine follow-up visits according to the established care pathway. Participants assigned to the intervention group will additionally receive a personalised educational programme lasting six months. This programme will be delivered monthly by a nurse through educational video pills and nurse-led teleconsultations. Participants will be required to watch the video pills and take part in teleconsultations.

Interventions

• Other TELESM-edu.nursing
  The teleconsultation intervention will be tailored according to participants' health literacy (HL) levels, adapting content complexity, information load, language, interaction style, and methods to verify understanding, while maintaining consistent participation goals. For patients with low HL, the intervention will focus on simplifying and progressively structuring information, prioritising essential and practical content. Understanding will be assessed using teach-back and Teach-to-Goal strat
• Other Standard
  The standard informational and educational programme provides that the physician and the health professionals involved in the care pathway, in particular the nurse, furnish patients taken care of at the Centre with information regarding the disease, the therapeutic and care pathway, and the management of the clinical condition. The standard intervention includes education on informed selection of information sources relevant to patients' areas of interest, and the clarification of any questions

Primary outcome measures

• Change in Navigational Health Literacy (Ability to Navigate Health Systems and Services) Assessed by the HLS19-NAV Instrument From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline, 3 months, and at the 6-month final follow-up.]
• Change in Health Literacy Level Assessed by the Single-Item Literacy Screener (SILS) From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline, 3 months, and at the 6-month final follow-up.]
• Change in Patient Satisfaction With Current Therapy Assessed by a Single-Item Satisfaction Measure From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline and at the 6-month final follow-up.]
• Change in Beliefs About the Necessity of Prescribed Medicines Assessed by the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific) Necessity Subscale From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline and at the 6-month final follow-up.]
• Change in Concerns About Prescribed Medicines Assessed by the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific) Concerns Subscale From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline and at the 6-month final follow-up.]
• Change in Trust in Nurses Assessed by the Trust in Nurses Scale (TNS) From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline, 3 months, and at the 6-month final follow-up.]
• Satisfaction of Patients' Informational Needs at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]
• Change in Disability Level Assessed by the Expanded Disability Status Scale (EDSS) From Baseline to 6-Month Follow-up [Time frame: Assessed at baseline and at the 6-month final follow-up.]

Secondary outcome measures (6)

• Feasibility of the TELESM-edu.nursing Programme Assessed by Participant Retention and Adherence Rates Over the 6-Month Study Period [Time frame: Assessed at 3 months and at the 6-month final follow-up.]
• Acceptability of the TELESM-edu.nursing Intervention Assessed by a TFA-Based Questionnaire at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]
• Usability of the TELESM-edu.nursing Intervention Assessed by a Single-Item Measure at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]
• Satisfaction With the TELESM-edu.nursing Intervention Assessed by a Single-Item Measure at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]
• Staff Satisfaction With the TELESM-edu.nursing Intervention Assessed Through Semi-Structured Interviews at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]
• Staff-Perceived Usability of the TELESM-edu.nursing Intervention Assessed Through Semi-Structured Interviews at 6-Month Follow-up [Time frame: Assessed at the 6-month final follow-up.]

Eligibility criteria

Inclusion criteria

• Patients of both sexes (male and female)
• Age 18 years or older
• Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), or secondary progressive multiple sclerosis (SPMS)
• Currently receiving pharmacological treatment for multiple sclerosis
• Expanded Disability Status Scale (EDSS) score of 7.5 or lower
• Ability to read and understand Italian
• Ability to provide written informed consent
• Access to a suitable device (smartphone, tablet, or computer with a webcam)
• Access to a home internet connection

Exclusion criteria

• Age younger than 18 years
• Expanded Disability Status Scale (EDSS) score higher than 7.5
• Presence of psychiatric disorders that may interfere with participation in the study
• Presence of cognitive impairment that may interfere with participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07640698 · TELESM1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗