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.

Study Overview

• Status: Completed
• Conditions: Vascular Disease
• Intervention / Treatment: Other: Verbal and written information; Other: Verbal and electronic 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland, 000
    • Midwestern Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall improvement in knowledge in a group of patients with vascular disease following the provision of information through verbal, written or electronically based sources.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of providing electronically based information to the vascular patient population	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	6 weeks

Collaborators and Investigators

• Sponsor: Mid Western Regional Hospital, Ireland
• Investigators: Principal Investigator: Stewart R Walsh, HSE and University of Limerick

Publications and helpful links

General Publications

• Lovell M, Harris K, Forbes T, Twillman G, Abramson B, Criqui MH, Schroeder P, Mohler ER 3rd, Hirsch AT; Peripheral Arterial Disease Coalition. Peripheral arterial disease: lack of awareness in Canada. Can J Cardiol. 2009 Jan;25(1):39-45. doi: 10.1016/s0828-282x(09)70021-2.
• Hirsch AT, Murphy TP, Lovell MB, Twillman G, Treat-Jacobson D, Harwood EM, Mohler ER 3rd, Creager MA, Hobson RW 2nd, Robertson RM, Howard WJ, Schroeder P, Criqui MH; Peripheral Arterial Disease Coalition. Gaps in public knowledge of peripheral arterial disease: the first national PAD public awareness survey. Circulation. 2007 Oct 30;116(18):2086-94. doi: 10.1161/CIRCULATIONAHA.107.725101. Epub 2007 Sep 17.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 4, 2013
• First Submitted That Met QC Criteria: March 4, 2013
• First Posted (Estimate): March 5, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 24, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Abdominal aortic aneurysm; Vascular disease; Patient information; Varicose veins; Web based information
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: INFO2013