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

NCT ID: NCT07179562

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-10-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

"motivational interviewing" program

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.

Group Type: EXPERIMENTAL

"motivational interviewing"

Intervention Type: OTHER

Randomization for "motivational interviewing"

Standard of care

Patients followed according to clinical practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"motivational interviewing"

Randomization for "motivational interviewing"

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

RICHELDI LUCA

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

7820

Identifier Type: -

Identifier Source: org_study_id