Cystic Fibrosis Clinical Trial
— HOME-CFOfficial title:
A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
NCT number | NCT02994706 |
Other study ID # | 2012135RM |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2006 |
Est. completion date | September 2018 |
Verified date | February 2019 |
Source | Heart of England NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing
recurrent chest infections and premature death due to lung failure. When patients develop
chest infections their symptoms usually slowly worsen over the course of several days to
weeks. Due to this gradual onset, patients often seek medical attention several days or weeks
after symptoms start to worsen. The Investigators believe that if they were able to monitor
patients more closely they could diagnose and treat chest infections earlier and consequently
improve health outcomes.
The HOMECF study aims to investigate whether home monitoring is beneficial for adults with
CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive
routine clinical care for 12 months. Subjects receiving home monitoring will measure their
lung function and symptoms twice weekly and this data will be transmitted to the medical team
by means of a modified mobile phone.
the Investigators hypothesize that home monitoring will allow them to diagnose chest
infections at an earlier stage and reduce hospital inpatient days. They will also assess the
subjects' experience of receiving home monitoring, the impact on body weight and lung
function and and conduct a full health economic analysis to assess value for money. They will
also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels
of inflammatory markers.
Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research
team are well placed to carry out the study because it is a large regional adult CF centre
with an excellent record of conducting clinical research.
Status | Completed |
Enrollment | 88 |
Est. completion date | September 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - confirmed diagnosis of CF - age over 18 years - the requirement for 1 or more admission to hospital to receive intravenous antibiotics over the preceding 24 months - clinically stable at the time of recruitment - Patients who give informed consent. Exclusion Criteria: - patients who are currently participating in another clinical trial (excluding observational studies) - pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks (since these factors prevent measurement of spirometry) - Sputum infection with Burkholderia cenocepacia or Mycobacterium abscessus - Current diagnosis of active allergic bronchopulmonary aspergillosis (ABPA) - Previous lung transplantation procedure. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Birmingham Heartlands Hospital | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Heart of England NHS Trust | National Institute for Health Research, United Kingdom, University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group | up to 12 months | ||
Secondary | Change in FEV1 in the home monitoring group compared to the routine clinical care group | up to 12 months | ||
Secondary | Change in FVC in the home monitoring group compared to the routine | up to 12 months | ||
Secondary | Days on oral and intravenous antibiotics in the home monitoring group compared to the routine clinical care group | Up to 12 months | ||
Secondary | Change in body weight in the home monitoring group compared to the routine clinical care group | Up to 12 months | ||
Secondary | Change in BMI in the home monitoring group compared to the routine clinical care group | Up to 12 months | ||
Secondary | Change in CFQ-R scores in the home monitoring group compared to the routine clinical care group | The Cystic Fibrosis Questionnaire Revised version (CFQ-R) is a multiple choice and likert questionnaire split into two sections: Demographics and Quality of Life. Answers of 'Always' or similar are deemed a higher value than 'Never' or similar. The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. never) than those that are higher values (e.g. 'always) | Up to 12 months | |
Secondary | Health economic analysis measured by EQ-5D-5L | The Euro Quality of Life (EQ5D) is a multiple choice questionnaire split onto sections including Mobility, Self-Care, Usual activities, Pain/Discomfort, and Anxiety/Depression. For each of these sections, it asks if a person always have issues, some issues or no issues (e.g. Mobility - I have no problems / I have some problems / I am confined to bed). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I have no issues) than those that are higher values (e.g. I am confined to bed). There is also a scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health) with 99 intervals in between whereby the patient marks where they feel their current health lays. | Up to 12 months | |
Secondary | Health economic analysis measured by ICECAP-A | The ICEpop CAPability measure for Adults (ICECAP-A) is a multiple choice questionnaire split onto sections including 'Feeling Settled and Secure, Love, Friendship and Support, Being Independent, Achievement and progress, and Enjoyment and pleasure. For each of these sections, it asks whether a person has no problem, some problems, many problems or total problem with a certain area (e.g. Being Independent - I can achieve in all aspects of my life / I can achieve in many aspects of my life / I can achieve in some aspects of my life / I am unable to be at all independent). The total score is gathered by calculating the amount of 'positive' and 'negative' answers - 'positive' answers are those that are lower values (e.g. I can achieve in all aspects of my life) than those that are higher values (e.g. I am unable to be at all independent). | Up to 12 months | |
Secondary | Costs associated with caring for each participant and the cost of conducting the study in the home monitoring group compared to the routine clinical care group | Up to 12 months | ||
Secondary | Patient experience assessed by a semi-structured qualitative interview in the home monitoring group compared to the routine clinical care group | Up to 12 months | ||
Secondary | Levels of relevant urine biomarkers in the home monitoring group associated with pulmonary exacerbations | Up to 12 months |
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