Efficacy of Patient Centred Information for Vascular Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01804972
First received: March 4, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

This study aims to determine the usefulness of providing patients with web-based electronically accessed patient information when compared to the provision of written information leaflets.


Condition Intervention Phase
Vascular Disease
Other: Verbal and written information
Other: Verbal and electronic information
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Patient Centred Information for Vascular Disease

Resource links provided by NLM:


Further study details as provided by Mid Western Regional Hospital, Ireland:

Primary Outcome Measures:
  • Overall improvement in knowledge in a group of patients with vascular disease following the provision of information through verbal, written or electronically based sources. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Patients will be randomised to receive either verbal and written information or verbal and electronically based information on their disease specific condition. Knowledge will be assessed through the use of a multi choice questionnaire at baseline prior to the provision of information on their condition and again at follow up 6 weeks later.


Secondary Outcome Measures:
  • Effectiveness of providing electronically based information to the vascular patient population [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    At follow patients will be asked to complete a questionnaire detailing their use of the information provided.

    The following measures will be recorded:

    Did you access the website address provided Y/N

    If Yes, How many times did you access the website (Specify) ____________________

    Did you find the website useful or informative Yes/No/Somewhat

    Did you read the information leaflet provided Y/N

    If Yes, How many times did you read the leaflet (Specify) ______________________

    Did you find the leaflet useful or informative Yes/No/Somewhat



Enrollment: 50
Study Start Date: May 2013
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Verbal and written infomation
Verbal and written information:Patients will receive both verbal information and written patient information leaflets
Other: Verbal and written information
Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
Experimental: Verbal and electronic information
Patient will receive both verbal information and a web address to access patient information electronically
Other: Verbal and electronic information
Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.

Detailed Description:

Hospitals and health care institutions attempt to provide information to patients through a variety of media including; written information, web-site based information and more recently through the use of smart phone based applications. Such educational campaigns have financial implications for hospitals and institutions.

The level of knowledge among patients with vascular disease of their pathology and its associated risk factors has been shown to be poor (Lovell et al 2009, Hirsch et al 2007). The optimum tool with which to provide information to patients with vascular disease has not been determined to date.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed abdominal aortic aneurysm, peripheral vascular disease or varicose veins
  • Capacity to and willingness to consent to participation in the study
  • Adult patients
  • In-patient or out-patient status

Exclusion Criteria:

  • Previously diagnosed with vascular disease
  • Limited capacity or unwilling to consent
  • Information already provided by hospital doctor
  • Cognitive/intellectual impairment/acquired brain injury/visual impairment
  • Qualified medical professionals
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01804972

Locations
Ireland
MidWestern Regional Hospital
Limerick, Ireland, 000
Sponsors and Collaborators
Mid Western Regional Hospital, Ireland
Investigators
Principal Investigator: Stewart R Walsh HSE and University of Limerick
  More Information

Publications:
Responsible Party: Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier: NCT01804972     History of Changes
Other Study ID Numbers: INFO2013
Study First Received: March 4, 2013
Last Updated: March 24, 2014
Health Authority: Ireland: MidWestern Regional hospital group research ethics committee

Keywords provided by Mid Western Regional Hospital, Ireland:
Patient information
Vascular disease
Abdominal aortic aneurysm
Varicose veins
Web based information

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014