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Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (SUPIRIO)

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ClinicalTrials.gov Identifier: NCT03567785
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Wim Wuyts, KU Leuven

Tracking Information
First Submitted Date May 9, 2018
First Posted Date June 25, 2018
Last Update Posted Date August 1, 2018
Actual Study Start Date July 17, 2018
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2018)
The prevalence of non-adherence to pirfenidone (=non-initiation, discontinuation and non-implementation). [ Time Frame: 1 year ]
All patients included in the study will be equipped with a Medication Event Monitoring System (MEMS) (Aardex, Ch) to monitor the medication adherence continuously and to characterise adherence patterns. The MEMS bottle contains a cap which holds a microchip and a pressure-release system that records and stores the exact time and date each time the patient opens the bottle.The monitoring device will be read by the investigator using the MedAmigoTM platform. Patterns of medication intake will be analysed by the investigator.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03567785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 13, 2018)
  • Impact of medication non-adherence on the forced vital capacity (FVC). [ Time Frame: 1 year ]
    FVC data will be retrieved from the medical file of the patient.
  • Impact of medication non-adherence on progression-free survival. [ Time Frame: 1 year ]
    Clinical data will be retrieved from the medical file of the patient.
  • Impact of medication non-adherence on quality of life measured with the EQ-5D-5L questionnaire. [ Time Frame: 1 year ]
    Patients will receive the EQ-5D-5L measuring their health-related quality of life. The EQ-5D-5L is a standardised self-report questionnaire developed by the EuroQol group measuring the perceived health status of patients. It consists of the EQ descriptive system comprising five dimensions and the EQ visual analogue scale (VAS). Each dimension of the EQ descriptive system (i.e. mobility, self-care, usual activities, pain/discomfort, anxiety/depression) has 5 levels of response options (i.e. 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems and 5= extreme problems) and the combined answers of the dimensions result in a five-digit number describing the patient's health. Patients are also asked to fill in the EQ VAS where they have to report their current perceived health status on a vertical analogue scale. This scale ranges from 'best imaginable health state, i.e. 100' to 'worst imaginable health state, i.e. 0'.
  • Impact of health literacy on therapy adherence. [ Time Frame: Baseline ]
    Health literacy will be assessed in this study because poor health literacy might be an important risk factor for therapy non-adherence and it was shown to be associated with a poorer capacity to comprehend and to follow medical advice as well as having poorer health outcomes. The self-administered single-item variant of the subjective health literacy screener (SHLS) will be given to the patients at baseline. In a validation study, the question 'how confident are you in filling out medical files by yourself' scored significantly better than two other investigated questions to detect patients with inadequate health literacy. This question will be scored on a 5-point likert scale (i.e. none, a little, some, most, all of the time), where a score between 0 and 2 (i.e. none, a little or some of the time) will be seen as inadequate health literacy.
  • Impact of depression on therapy adherence [ Time Frame: 1 year ]
    The patient health questionnaire (PHQ-9) will be used to assess symptoms of depression, as it is a reliable and validated self-administered nine-item questionnaire based on the nine diagnostic criteria for DSM-IV depressive disorders. The score ranges between 0 and 27, since each item can be scored from 0 (not at all) to 3 (nearly every day). Cut-off points of 5, 10, 15, and 20 represent the lower limits of mild, moderate, moderately severe and severe depression, respectively.
  • Impact of barriers on therapy adherence [ Time Frame: 1 year ]
    Barriers will be assessed with the adapted version of the 'immunosuppressive medication adherence barrier scale' (IMAB) developed by the transplant360 Task force. The questionnaire consists of 27 items that are scored on a 5-point likert scale (i.e. never, rarely, sometimes, often, always) resulting in a median score for all patients. Several barriers will be explored such as health beliefs, forgetfulness, disruption of the routine and complexity of the regimen.
  • Impact of medication non-adherence on quality of life measured with the K-BILD questionnaire. [ Time Frame: 1 year ]
    Patients will receive the K-BILD questionnaire measuring their health-related quality of life. The K-BILD is a 15-item self-completed questionnaire measuring the health-related quality of life (HRQL) of patients with interstitial lung disease. It consists of three domains: breathlessness and activities, psychological and chest symptoms. Each question has a seven-point response scale resulting in a total score ranging between 0 and 100 with a higher score reflecting a higher HRQL.
  • Impact of medication non-adherence on quality of life measured with the SGRQ. [ Time Frame: 1 year ]
    The St- George's Respiratory questionnaire (SGRQ) is a 50-item questionnaire consisting of two parts. The first part evaluates the symptoms (i.e. cough, sputum production, wheezing and breathlessness) and the second part evaluates the activities (i.e. activities causing breathlessness or limited by breathlessness) and the impacts (e.g. on employment, daily life, etc.). Each question is scored as positive (i.e. =1) or negative (i.e. =0) and the total score is expressed as a percentage where 0% represents the best possible health status and 100% the worst possible health status. A total score can be obtained as well as a score for each of the three components.
  • Impact of non-adherence on the diffusing capacity for carbon monoxide (DLco). [ Time Frame: 1 year ]
    DLco data will be retrieved from the medical file of the patient.
  • Adherence to Pirfenidone [ Time Frame: 1 year ]
    Patients will report their medication adherence by means of the validated Basel Adherence Assessment Scale for Immunosuppressive Medications (BAASIS). The questionnaire includes five questions about taking, dosing and timing of medication intake, as well as drug holidays, and treatment discontinuation. All deviating answers (i.e. questions answered by 'yes') will be defined as non-adherence.
  • Knowledge that patients have on their disease and treatment [ Time Frame: 1 year ]
    Patients need to have the psychological capacity to adhere to their treatment meaning that they need to have adequate knowledge about their disease (e.g. severity of the disease) and treatment (e.g. side effects, dosing regimen). A specific questionnaire developed for this study will be given to patients to measure their knowledge about IPF and Pirfenidone. It consists of 6 true/false/I don't know questions on the treatment of IPF. Correct answers will receive a point resulting in a score ranging between 0 and 6 with higher scores reflecting a better knowledge.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2018)
  • Adherence to limited alcohol intake [ Time Frame: 1 year ]
    Patients are advised by the healthcare provider to limit their alcohol intake. Alcohol intake will be assessed using the AUDIT-C questionnaire. It consists of three questions with each five possible answers (i.e. a= 0 points, b= 1 point, c= 2 points, d= 3points and e= 4 points). A score of 4 or more in men and 3 or more in women is considered positive for identifying at risk drinking, defined as drinking at a level that might contain health risks.
  • Physical activity of patients [ Time Frame: 1 year ]
    To measure the physical activity in this study, the two-item Brief Physical Activity Assessment Tool based on the physical activity guidelines, will be used. The total score ranges between 0 and 8 with a score of 4 or more reflecting an adequate physical activity level.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Official Title Supporting Adherence to Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis: the Key to Successful Treatment Outcomes: the SUPIRIO-study
Brief Summary Idiopathic pulmonary fibrosis (IPF) is an irreversible, chronic and relentless lung disorder of unknown aetiology leading ultimately to respiratory insufficiency and death within 2-5 years after diagnosis. Treatment with the anti-fibrotic drug Pirfenidone slows down the disease progression and reduces the risk of acute exacerbations. Unfortunately, Pirfenidone represents a complex pharmacological regimen, in which patients have to take 3 tablets 3 times a day at mealtime. As for all chronically ill patients, adherence to a complex regimen might be challenging and nonadherence might reduce the full potential of Pirfenidone in patients with IPF. Due to extremely sparse availability of evidence on treatment adherence in the IPF population, it needs to be fully ascertained if, why, when and how many patients discontinue treatment or struggle to correctly take Pirfenidone as prescribed.
Detailed Description

Idiopathic pulmonary fibrosis (IPF) is an irreversible, chronic and relentless lung disorder of unknown aetiology characterised by a progressive destruction of lung parenchyma leading ultimately to respiratory insufficiency and death within 2-5 years after diagnosis. Treatment with the anti-fibrotic drug Pirfenidone slows down the disease progression and reduces the risk of acute exacerbations. Evidence also showed that treatment with Pirfenidone should be continued lifelong to maximise outcomes even in patients who experience disease progression during therapy. Unfortunately, Pirfenidone represents a complex pharmacological regimen, in which patients have to take 3 tablets 3 times a day at mealtime with a titration period in the first 3 weeks (i.e. 3 times 1 tablet of 267 mg during the first week, 3 times 2 tablets during the second week, and 3 times 3 tablets a week from week 3 onwards). As for all chronically ill patients, adherence to a complex regimen might be challenging and nonadherence might reduce the full potential of Pirfenidone in patients with IPF. Adherence is defined as "the extent to which a person' s behaviour - taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a health care provider"(WHO, 2003) and encompasses three phases namely, initiation, implementation and persistence.

Due to extremely sparse availability of evidence on treatment adherence in the IPF population, it needs to be fully ascertained if, why, when and how many patients discontinue treatment or struggle to correctly take Pirfenidone as prescribed. Furthermore, the investigators also don't know what the impact is of non-adherence to Pirfenidone on clinical outcomes in patients with IPF and whether good adherence is associated with a better health related quality of life.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients with a recent diagnosis of IPF and starting on Pirfenidone at the University hospitals of Leuven will be invited to participate in the SUPIRIO study.
Condition
  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Fibrosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 13, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of IPF based on the 2011 ATS/ERS/JRS/LATA diagnostic criteria
  • Patients who will start treatment with pirfenidone
  • Patients of 18 years or older
  • Oral fluency in Dutch or French
  • Being able to provide written informed consent

Exclusion Criteria:

  • Patients not managing their medications independently (e.g. Institutionalized patients, patients living in a nursing home or patients receiving homecare from a nurse). However, patients receiving help to prepare their medication from informal caregivers (i.e. family) are allowed to participate in the study.
  • Patients not having their follow-up consultations at the University hospitals of Leuven.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Wim Wuyts, Professor +32 16 34 68 02 wim.wuyts@uzleuven.be
Contact: Anouk Delameillieure +32 16 37 70 52 anouk.delameillieure@kuleuven.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03567785
Other Study ID Numbers S61427
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Professor Wim Wuyts, KU Leuven
Study Sponsor KU Leuven
Collaborators Not Provided
Investigators
Principal Investigator: Wim Wuyts Catholic University Leuven
PRS Account KU Leuven
Verification Date July 2018