Evaluation of Patient Access to People With Cystic Fibrosis (CF) and Healthcare Professionals

NCT06122025 | Completed

• 1 other identifier: Patient Access V1.0, 12-JUN-17
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is one of the most common inherited conditions in the United Kingdom (UK). There are 10,810 people living with CF in the UK, with median predicted survival now 47 years old. People with CF have multiple medical treatments to do on a daily basis, and the treatment burden is increasing. Adherence to treatment plays an important role in health outcomes and survival in CF. Online access to their own health care records gives people an increased control over their own health, greater understanding of their conditions and has a potential to improve adherence to care plans and medications. Whilst implementation of electronic records is established in primary care, there has been a much poorer roll out of electronic care records in the secondary care system. Leeds Teaching Hospitals CF Unit is a regional centre with around 650 adult and paediatric registered patients. Handwritten and typed paper records of patients under the care of the CF unit in Leeds were replaced in 2007 by electronic healthcare records (EHR; EMIS®). Patients view and obtain graphical feedback at each clinic visit including trends in parameters such as lung function, weight and inflammatory markers. In partnership with Egton Medical Information Systems (EMIS) web (EMIS®), a modification allowing secondary care access to patient records has been developed. In a structured programme of research, the Leeds Adult CF Unit have firstly evaluated the implementation of the EHR in secondary care in terms of service delivery and cost improvement. In the second phase, the investigators sought patient feedback regarding which aspects of their EHR people with CF wish to access, and their priorities for development. This has informed the third phase in which the aim is to explore the impact of patient access to their EHR. The aims of the trial are 1. To evaluate the feasibility, benefits and acceptability to patients and health care professionals of providing secure access of linked secondary care and patient's Personal Health Records in CF, and 2. To explore technological usability, future functionality and the impact of the shared records on clinical resources, communication and patient and health care professional satisfaction.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• levels of anxiety

  The effect on levels of anxiety of people with CF as measured by changes in the General Anxiety Disorder-7 (GAD-7) questionnaire. This questionnaire consists of 7 items (and one non-scored item which assigns weight to the degree to which anxiety problems have affected the patient's level of function), assessing over the last 2 weeks, how often patients have been bothered by anxiety related problems. Possible scores range from 0 (not at all) to 3 (nearly every day), with total scores of 0-5, 6-10. 11-15, and 15-21 representing mild, moderate, moderately severe and severe anxiety respectively.

  6 months

• levels of quality of life

  The effect on quality of life of people with CF as measured by changes in the Cystic Fibrosis Questionnaire-Revised (CFQ-R) questionnaire. The CFQ-R is a disease-specific health-related qualify of life measure for people with CF and has undergone extensive reliability and validity testing. This questionnaire consists of 50 items, and assesses the following domains; Physical Functioning, Vitality, Health Perceptions, Respiratory Symptoms, Treatment Burden, Role Functioning, Emotional Functioning, and Social Functioning. Scores ranged from 0 to 100, with higher scores indicating better health-related qualify of life.

  6 months

Secondary Outcomes (8)

• levels of depression

  6 months

• Self-efficacy

  6 months

• Patient motivation towards health and care

  6 months

• Patient and provider relationships

  6 months

• Computer literacy

  6 months

Study Arms (2)

Intervention [access to electronic healthcare records; EHR]

ACTIVE COMPARATOR

For those in the intervention group, the participant will receive personalised access to their secondary electronic healthcare record (EHR) for 6 months. Individual access will be activated by the clinical team at the start of the study and will include views for; 1. Current problems 2. Current medication 3. Test requests 4. Letters 5. Consultations 6. Allergies 7. Immunisations

Device: Patient Access

Control [no access]

NO INTERVENTION

For those in the control group, participants will not receive access to their electronic healthcare record for the 6 month period. After the study, participants in the control group will have the opportunity to have access to their healthcare records

Interventions

Patient Access DEVICE

A 6-month pilot prospective interventional study with an independent groups design.

Intervention [access to electronic healthcare records; EHR]

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF (confirmed via genetic testing or sweat chloride tests)
• Aged 17 years and over
• Males and females
• Able to give written informed consent
• Records stored electronically on the EHR system at the Regional Leeds Adult CF Unit

You may not qualify if:

• Taking part in a clinical trial which prohibits patients taking part in other research

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• University of Leeds: collaborator
• Cystic Fibrosis Trust: collaborator
• Leeds Beckett University: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

• Chadwick HK, Sawant A, White H, Gillgrass L, Spoletini G, Clifton IJ, Etherington C, Peckham DG. Providing Mobile Patient Access to Their Electronic Secondary Care Patient Record in Adults With Cystic Fibrosis: Results of a Prospective, Parallel, Randomized Open-Pilot Quantitative Study. JMIR Form Res. 2025 Dec 25;9:e69747. doi: 10.2196/69747.

  PMID: 41447265 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Daniel Peckham

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 8, 2023
• Study Start: December 11, 2017
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

GB (1)