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Efficacy of Patient Centred Information for Vascular Disease

Primary Purpose

Vascular Disease

Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
Verbal and written information
Verbal and electronic information
Sponsored by
Mid Western Regional Hospital, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vascular Disease focused on measuring Patient information, Vascular disease, Abdominal aortic aneurysm, Varicose veins, Web based information

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MidWestern Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Verbal and written infomation

Verbal and electronic information

Arm Description

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

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

Outcomes

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.
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
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

Full Information

First Posted
March 4, 2013
Last Updated
March 24, 2014
Sponsor
Mid Western Regional Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01804972
Brief Title
Efficacy of Patient Centred Information for Vascular Disease
Official Title
Efficacy of Patient Centred Information for Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid Western Regional Hospital, Ireland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease
Keywords
Patient information, Vascular disease, Abdominal aortic aneurysm, Varicose veins, Web based information

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal and written infomation
Arm Type
Active Comparator
Arm Description
Verbal and written information:Patients will receive both verbal information and written patient information leaflets
Arm Title
Verbal and electronic information
Arm Type
Experimental
Arm Description
Patient will receive both verbal information and a web address to access patient information electronically
Intervention Type
Other
Intervention Name(s)
Verbal and written information
Intervention Description
Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
Intervention Type
Other
Intervention Name(s)
Verbal and electronic information
Intervention Description
Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.
Primary Outcome Measure Information:
Title
Overall improvement in knowledge in a group of patients with vascular disease following the provision of information through verbal, written or electronically based sources.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Effectiveness of providing electronically based information to the vascular patient population
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart R Walsh
Organizational Affiliation
HSE and University of Limerick
Official's Role
Principal Investigator
Facility Information:
Facility Name
MidWestern Regional Hospital
City
Limerick
ZIP/Postal Code
000
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19148341
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. doi: 10.1016/s0828-282x(09)70021-2.
Results Reference
background
PubMed Identifier
17875966
Citation
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.
Results Reference
background

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Efficacy of Patient Centred Information for Vascular Disease

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