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

March 4, 2013
March 24, 2014
May 2013
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01804972 on ClinicalTrials.gov Archive Site
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

Same as current
Not Provided
Not Provided
 
Efficacy of Patient Centred Information for Vascular Disease
Efficacy of Patient Centred Information for Vascular Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Vascular Disease
  • 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
  • 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.
  • Active Comparator: Verbal and written infomation
    Verbal and written information:Patients will receive both verbal information and written patient information leaflets
    Intervention: Other: Verbal and written information
  • Experimental: Verbal and electronic information
    Patient will receive both verbal information and a web address to access patient information electronically
    Intervention: Other: Verbal and electronic information

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01804972
INFO2013
Yes
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
Mid Western Regional Hospital, Ireland
Not Provided
Principal Investigator: Stewart R Walsh HSE and University of Limerick
Mid Western Regional Hospital, Ireland
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP