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NOT YET RECRUITING
NCT07640698
NA

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

Sponsor: G. d'Annunzio University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-07

Completion Date

2027-06

Last Updated

2026-06-11

Healthy Volunteers

No

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 strategies. Nurses will provide supportive materials, including brochures with images, diagrams, and key messages, sent via email after each session. For patients with adequate HL, the intervention will include more in-depth content and encourage critical discussion. Additional educational materials and reliable online resources will be provided after teleconsultations to support further learning.

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 or informational requests that arise during the care pathway.