Efficacy of Patient Centred Information for Vascular Disease

Vascular Disease Clinical Trial

Official title:

Efficacy of Patient Centred Information for Vascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804972
• Other study ID #: INFO2013
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2013
• Last updated: March 24, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Mid Western Regional Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: MidWestern Regional hospital group research ethics committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Vascular Disease
• Vascular Diseases

Intervention

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
• 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.

Locations

Country	Name	City	State
Ireland	MidWestern Regional Hospital	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
Mid Western Regional Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (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. Epub 2007 Sep 17. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No