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NCT Number: NCT07640698

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

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.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Telenursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TELESM-edu.nursing

Other

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.

standard

Other

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.

Primary outcomes

  1. 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.

    Navigational Health Literacy will be assessed using the Italian version of the HLS19-NAV Instrument for measuring Navigational Health Literacy. The HLS19-NAV includes 12 items assessing the ability to find, understand, appraise, and apply information needed to navigate health systems and services. Items are rated on a 4-point Likert scale, where 1 = very difficult and 4 = very easy. The total HLS19-NAV score will be calculated as the percentage of positive responses ("easy" or "very easy") among valid responses, provided that at least 80% of items are completed. Scores range from 0 to 100 percentage points, with higher scores indicating better navigational health literacy.

    Unit of Measure:

    Percentage points on the HLS19-NAV score, range 0-100.

  2. 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.

    Health literacy level will be assessed using the Italian version of the Single-Item Literacy Screener (SILS). The SILS consists of a single item assessing how often an individual requires assistance when reading and understanding health-related information. Responses are rated on a 5-point Likert scale ranging from 1 (never) to 5 (always). Scores range from 1 to 5, with higher scores indicating lower health literacy. Based on established SILS cut-offs, participants will be classified as having low health literacy (SILS score ≥3) or adequate health literacy (SILS score <3).

    Unit of Measure:

    Number or percentage of participants classified as having low or adequate health literacy.

  3. 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.

    Patient satisfaction with current therapy will be assessed using a single-item measure. Participants will be asked to indicate their level of satisfaction with their current therapy using three response categories: very satisfied, moderately satisfied, or little satisfied. Participants reporting dissatisfaction will also be asked to indicate the main reason(s) for dissatisfaction, including mode or frequency of administration, side effects, or symptom worsening.

    Unit of Measure:

    Patient satisfaction category (very satisfied, moderately satisfied, or little satisfied).

  4. 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.

    Beliefs about the necessity of prescribed medicines will be assessed using the Necessity subscale of the Italian version of the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific). The Necessity subscale comprises 5 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 5 to 25, with higher scores indicating stronger beliefs in the necessity of prescribed medications.

    Unit of Measure:

    BMQ-Specific Necessity subscale score (5-25 points).

  5. 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.

    Concerns about prescribed medicines will be assessed using the Concerns subscale of the Italian version of the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific). The Concerns subscale comprises 5 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 5 to 25, with higher scores indicating greater concerns regarding the potential adverse consequences of prescribed medications.

    Unit of Measure:

    BMQ-Specific Concerns subscale score (5-25 points).

  6. 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.

    Trust in nurses will be assessed using the Italian version of the 5-item Trust in Nurses Scale (TNS). The scale includes 5 items describing nurses' activities and patients' feelings regarding nursing care. Responses are rated on a 6-point Likert scale ranging from 1 (never) to 6 (always). The total TNS score is calculated by summing the scores of the five items, resulting in a score ranging from 5 to 30. Higher scores indicate greater trust in nurses.

    Unit of Measure:

    Trust in Nurses Scale (TNS) total score (range 5-30).

  7. Satisfaction of Patients' Informational Needs at 6-Month Follow-up

    Time frame: Assessed at the 6-month final follow-up.

    Satisfaction of patients' informational needs will be assessed through analysis of the computerized database used by the nurse to document informational needs expressed during teleconsultation sessions and those subsequently addressed. The analysis will be integrated with qualitative data obtained from audio-recorded teleconsultation transcripts. Informational needs will be classified as met when the nurse provided information or clarification during the teleconsultation and the patient confirmed understanding or resolution of the expressed informational need.

    Unit of Measure:

    Percentage of informational needs classified as met.

  8. 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.

    Disability level will be assessed by a neurologist using the Expanded Disability Status Scale (EDSS). The EDSS evaluates neurological impairment and disability in people with multiple sclerosis. Scores range from 0 to 10, with higher scores indicating greater disability.

    Unit of Measure:

    EDSS score (range 0-10).

Secondary outcomes

  1. 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.

    Feasibility of the TELESM-edu.nursing programme will be assessed in the intervention group by evaluating participant retention, adherence, and dropout rates at 3 months and 6 months. The intervention will be considered feasible if at least 80% of enrolled participants continue to participate in the Telenursing programme at each assessment time point. A dropout rate of 20% or greater will be considered indicative of potential feasibility concerns.

    Unit of Measure:

    Percentage of enrolled participants retained in and adhering to the intervention; dropout rate (%).

  2. 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.

    Acceptability of the TELESM-edu.nursing intervention will be assessed using five items adapted from the Generic TFA-Based Questionnaire. The items assess five Theoretical Framework of Acceptability (TFA) constructs: Affective Attitude, Burden, Ethicality, Self-efficacy, and Opportunity Costs. Items are rated on a 5-point Likert scale. Burden and Opportunity Costs items will be reverse-scored so that higher values indicate greater acceptability. The overall acceptability score will be calculated as the mean of the five TFA construct items, with higher scores indicating greater intervention acceptability.

    Unit of Measure:

    Acceptability score (1-5).

  3. 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.

    Usability of the TELESM-edu.nursing intervention will be assessed using a single-item measure developed by the research team to evaluate the perceived ease of use of and participation in the educational programme. Responses are rated on a 5-point Likert scale, with higher scores indicating greater perceived usability.

    Unit of Measure:

    Usability score (1-5).

  4. 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.

    Overall satisfaction with the TELESM-edu.nursing intervention will be assessed using a single-item measure developed by the research team. Responses are rated on a 5-point Likert scale, with higher scores indicating greater satisfaction with the intervention.

    Unit of Measure:

    Satisfaction score (1-5).

  5. 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.

    Satisfaction with the TELESM-edu.nursing intervention among staff involved in the intervention will be assessed through semi-structured interviews conducted at the end of the study. Interviews will be guided by a predefined interview guide developed by the research team and informed by the literature. Audio-recorded interviews will be transcribed verbatim and analysed qualitatively to identify themes related to staff satisfaction with the intervention.

    Unit of Measure:

    Qualitative themes related to staff satisfaction.

  6. 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.

    Perceived usability of the TELESM-edu.nursing intervention among staff involved in the intervention will be assessed through semi-structured interviews conducted at the end of the study. Interviews will be guided by a predefined interview guide developed by the research team and informed by the literature. Audio-recorded interviews will be transcribed verbatim and analysed qualitatively to identify themes related to the perceived usability of the intervention.

    Unit of Measure:

    Qualitative themes related to staff-perceived usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Simonetti, Associate Professor

CONTACT

[email protected]

+39 (0871) 541205

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Acronym: TELESM-edu

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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