NCT05261412

Brief Summary

This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with varicose veins. Patients will be randomised to receive standard (verbal discussion and written information pamphlet) consent or a digital health education tool (dHET). The primary endpoints will be feasibility and practicality of introducing dHET into a busy day surgery practice, secondary endpoints will included knowledge recall of essential information, patient anxiety, patient satisfaction and the time spent in person with the responsible surgeon and number of questions asked prior to signing the consent document.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

February 9, 2022

Last Update Submit

April 22, 2024

Conditions

Varicose Veins

Keywords

Informed consentEducational toolDigital ConsentTelemedicineKnowledge recallAnxietySatisfaction

Outcome Measures

Primary Outcomes (7)

  • Eligible participants

    Number of eligible participants (meeting inclusion criteria)

    Through study completion, an average of 12 months

  • Recruitment rate

    Number of participants consenting to participate

    Through study completion, an average of 12 months

  • Retention rate

    (Number of patients who consent to participation) minus (number of patients who voluntarily withdraw) divided by (number of subjects who enrol)

    Through study completion, an average of 12 months

  • Acceptability

    Number of patients declining to participate, reasons for declining, number of patients withdrawing consent

    Through study completion, an average of 12 months

  • Adherence to protocol

    Number of patients who adhered to assigned intervention protocol, also includes the proportion of complete data for each outcome measure

    Through study completion, an average of 12 months

  • Barriers to assigned intervention

    Number of patients not randomised due to staffing or time constraints (with reason recorded), technology issues with tablet/dHET/link to knowledge quiz/ internet access

    Through study completion, an average of 12 months

  • Time

    Time (seconds) taken to complete the assigned intervention (and any delays caused as a result)

    Immediately post intervention

Secondary Outcomes (5)

  • Knowledge

    Baseline, immediately after intervention, delayed (two week follow up)

  • Patient Anxiety

    Baseline, immediately after intervention, delayed (two week follow up)

  • Patient Satisfaction

    Immediately after intervention and delayed (two week follow up)

  • Time spent face to face with surgeon

    Post intervention (day of surgery)

  • Questions asked

    Post intervention (day of surgery)

Study Arms (2)

Standard Consent (Control)

ACTIVE COMPARATOR

Standard consent (written patient information leaflet (PIL) + verbal discussion with the responsible surgeon) for EVTA followed by signing of consent.

Other: Standard Consent

Digital health education tool (dHET)

EXPERIMENTAL

dHET for EVTA + verbal discussion with the responsible surgeon followed by signing of consent.

Other: Digital health education tool (dHET)

Interventions

Standard ConsentOTHER

Participants in the control arm will undergo Standard Consent which will consist of paper PIL provided by EIDO healthcare followed by a verbal discussion (standardized by following a checklist of topics to discuss) with the responsible consultant surgeon and signing of the consent form. The time taken to read the PIL (self-recorded by the patient) will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.

Also known as: Paper consent
Standard Consent (Control)
Digital health education tool (dHET)OTHER

Participants randomized to the intervention dHET will receive the dHET followed by a verbal discussion (as above) and signing of the consent form. The dHET will be delivered on a tablet computer and facilitated by a research assistant who will ensure all technological issues are overcome but will not engage with the participant with regard facilitating better understanding of the content. The digital offering will be interactive; participants will be able to traverse through each section at their own pace with the ability to re-visit sections. It also contains a two-minute narrated animation of the procedure, which can played, rewinded or fast forward. The time spent reading each section of the dHET and time spent watching the animation will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.

Also known as: Educational tool, Multimedia consent
Digital health education tool (dHET)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Deemed suitable for EVTA by treating surgeon
  • First procedure for superficial venous incompetence
  • Full consent
  • \>18 years
  • Proficient in English

You may not qualify if:

  • Redo or second procedure for superficial venous incompetence (in same or opposite leg)
  • Cognitive impairment or unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bon Secours Hospital

Dublin, D09YN97, Ireland

Location

Related Publications (16)

  • Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.

    PMID: 10396491BACKGROUND

  • Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg. 1999 Oct;30(4):710-9. doi: 10.1016/s0741-5214(99)70110-2.

    PMID: 10514210BACKGROUND

  • MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.

    PMID: 12042731BACKGROUND

  • Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.

    PMID: 23769603BACKGROUND

  • van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.

    PMID: 18692348BACKGROUND

  • Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

    PMID: 21536172BACKGROUND

  • National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (NICE); 2013 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK264166/

    PMID: 25535637BACKGROUND

  • Medical Council, The Guide to Professional Conduct and Ethics for Registered Medical Practitioners [2009] para, 9.2

    BACKGROUND

  • Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250.

    PMID: 25714163BACKGROUND

  • Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.

    PMID: 1556799BACKGROUND

  • Gartner FR, Bomhof-Roordink H, Smith IP, Scholl I, Stiggelbout AM, Pieterse AH. The quality of instruments to assess the process of shared decision making: A systematic review. PLoS One. 2018 Feb 15;13(2):e0191747. doi: 10.1371/journal.pone.0191747. eCollection 2018.

    PMID: 29447193BACKGROUND

  • Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.

    PMID: 26215573BACKGROUND

  • Couet N, Desroches S, Robitaille H, Vaillancourt H, Leblanc A, Turcotte S, Elwyn G, Legare F. Assessments of the extent to which health-care providers involve patients in decision making: a systematic review of studies using the OPTION instrument. Health Expect. 2015 Aug;18(4):542-61. doi: 10.1111/hex.12054. Epub 2013 Mar 4.

    PMID: 23451939BACKGROUND

  • Pascoe GC. Patient satisfaction in primary health care: a literature review and analysis. Eval Program Plann. 1983;6(3-4):185-210. doi: 10.1016/0149-7189(83)90002-2.

    PMID: 10299618BACKGROUND

  • Weinstein RS, Lopez AM, Joseph BA, Erps KA, Holcomb M, Barker GP, Krupinski EA. Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers. Am J Med. 2014 Mar;127(3):183-7. doi: 10.1016/j.amjmed.2013.09.032. Epub 2013 Oct 29.

    PMID: 24384059BACKGROUND

  • Kiernan A, Boland F, Moneley D, Doyle F, Harkin DW. Varicose Vein Education and Informed coNsent (VVEIN) study: a randomised controlled pilot feasibility study. Pilot Feasibility Stud. 2023 Jun 22;9(1):104. doi: 10.1186/s40814-023-01336-9.

    PMID: 37349825DERIVED

MeSH Terms

Conditions

Varicose VeinsAnxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMental DisordersBehavior

Study Officials

  • Denis Harkin

    Royal College of Surgeons, Ireland

    STUDY DIRECTOR

  • Aoife Kiernan

    Royal College of Surgeons, Ireland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 2, 2022

Study Start

April 4, 2022

Primary Completion

July 1, 2023

Study Completion

July 31, 2023

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)