Efficacy of Patient Centred Information for Vascular Disease

NCT01804972 | Completed Phase 2 DMC

• 1 other identifier: INFO2013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Disease

Keywords

Patient information; Vascular disease; Abdominal aortic aneurysm; Varicose veins; Web based information

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of providing electronically based information to the vascular patient population

  6 weeks

Study Arms (2)

Verbal and written infomation

ACTIVE COMPARATOR

Verbal and written information:Patients will receive both verbal information and written patient information leaflets

Other: Verbal and written information

Verbal and electronic information

EXPERIMENTAL

Patient will receive both verbal information and a web address to access patient information electronically

Other: Verbal and electronic information

Interventions

Verbal and written information OTHER

Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets

Verbal and written infomation

Verbal and electronic information OTHER

Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.

Verbal and electronic information

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid Western Regional Hospital, Ireland: lead

Study Sites (1)

MidWestern Regional Hospital

Limerick, Limerick, 000, Ireland

Location

Related Publications (2)

• 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.

  PMID: 19148341 BACKGROUND

• 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.

  PMID: 17875966 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Aortic Aneurysm, Abdominal; Varicose Veins

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Aortic Aneurysm; Aneurysm; Aortic Diseases

Study Officials

• Stewart R Walsh

  HSE and University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Stewart Walsh

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 5, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 26, 2014

Record last verified: 2014-03

Locations

IE (1)