Vascular DiseasePhase 2NCT01804972
Efficacy of Patient Centred Information for Vascular Disease
A Phase 2 study testing Verbal and written information and Verbal and electronic information in people with Vascular Disease, run by Mid Western Regional Hospital, Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Disease
- What is being tested?
- Verbal and written information and Verbal and electronic information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIreland
- Study dates
- May 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vascular Disease
- Being tested
- Verbal and written information, Verbal and electronic information
- Keywords
- Patient information, Vascular disease, Abdominal aortic aneurysm, Varicose veins, Web based information
- Medical subject headings
- Vascular Diseases, Aortic Aneurysm, Abdominal, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal and written informationOther
Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
Verbal and electronic informationOther
Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.
| Study group | Role | What they receive |
|---|---|---|
| Verbal and written infomation | Active comparator | Verbal and written information:Patients will receive both verbal information and written patient information leaflets Receives: 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 Receives: Other: Verbal and electronic information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid Western Regional Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
- Investigators
- Stewart R Walsh, Principal investigator, HSE and University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804972
- Sponsor's protocol ID
- INFO2013
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2013
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19148341Hirsch 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.
PubMed 17875966
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Patient Centred Information for Vascular Disease
- ClinicalTrials.gov ID
- NCT01804972
- Acronym / sponsor ID
- INFO2013
- Conditions
- Vascular Disease
- Keywords
- Patient information, Vascular disease, Abdominal aortic aneurysm, Varicose veins, Web based information
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mid Western Regional Hospital, IrelandUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal and written infomation | Active comparator | Other: Verbal and written informationVerbal and written information:Patients will receive both verbal information and written patient information leaflets |
| Verbal and electronic information | Experimental | Other: Verbal and electronic informationPatient will receive both verbal information and a web address to access patient information electronically |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal and written informationPatients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets | Other | Verbal and written infomation |
| Verbal and electronic informationPatients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information. | Other | Verbal and electronic information |
Primary outcome
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
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.
1 secondary outcome
Effectiveness of providing electronically based information to the vascular patient population
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Background: PubMed 19148341Lovell 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.
- Background: PubMed 17875966Hirsch 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.
Related trials for Vascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart R Walsh principal investigator
HSE and University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verbal and written information and Verbal and electronic information in people with Vascular Disease, run by Mid Western Regional Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804972, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.