Motivational Interviewing Program on the Self-Care in Idiopathic Pulmonary Fibrosis

NCT07179562 | Not Yet Recruiting

• 1 other identifier: 7820
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

A specific tool developed to measure self-care in patients with Idiopathic Pulmonary Fibrosis (IPF) is the SC-IPFI, which is an adaptation of an already validated instrument for COPD. It is important to assess how motivational interviewing can influence the self-care behaviors of these patients, better evaluate their level of disease management, prevent the risk of exacerbations, and guide educational interventions. The primary objective of this study is to evaluate the effectiveness of a motivational interviewing program delivered remotely through video calls and digital platforms in improving the levels of self-care maintenance, self-care monitoring, and self-care management in patients with IPF. The study will also assess the effectiveness of the remotely delivered motivational interviewing program on self-efficacy, anxiety, disease-specific quality of life, therapy adherence, cough, dyspnea, exacerbations, and hospital admissions.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• Il Self Care Index for Pulmonary Idiopatic Fibrosis (SC-IPFI)

  The SC-IPFI was derived from a similar tool used for COPD and adapted for idiopathic pulmonary fibrosis. The instrument assesses self-care in fibrotic patients using separate scales for the three dimensions of self-care: self-care maintenance, self-care monitoring, and self-care management. Each scale has a standardized score ranging from 0 to 100, with higher scores indicating better self-care.

  6 months

Study Arms (2)

"motivational interviewing" program

EXPERIMENTAL

The intervention in the experimental group will consist of a Motivational Interviewing (MI) program conducted in accordance with the Motivational Interviewing Treatment Integrity (MITI) guidelines , lasting 6 months and delivered through video calls and an online platform.

Other: "motivational interviewing"

Standard of care

NO INTERVENTION

Patients followed according to clinical practice.

Interventions

"motivational interviewing" OTHER

Randomization for "motivational interviewing"

"motivational interviewing" program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with idiopathic pulmonary fibrosis according to the 2018 guidelines of the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association,
• Diagnosed with IPF for at least 1 year,
• Aged 18 years or older,
• Able to express willingness and provide consent to participate in the study,
• In possession of a tablet, smartphone, or computer and internet access via mobile or fixed network.

You may not qualify if:

• Diagnosed with dementia,
• Unable to speak, read, or write in Italian,
• Legally blind or deaf,
• In advanced stage of disease (receiving oxygen therapy at 10 to 15 liters per minute).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to the motivational interviewing intervention group (experimental group) and the standard care group (control group).

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09