NCT02742025

Brief Summary

The main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the Nîmes University Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

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

April 7, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
3.6 years until next milestone

Study Start

First participant enrolled

November 19, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

2.5 years

First QC Date

April 7, 2016

Last Update Submit

June 22, 2023

Conditions

Preoperative Anxiety

Keywords

Coronary Angiography

Outcome Measures

Primary Outcomes (1)

  • Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Day 0 (within 1 hour preceding a coronography)

Secondary Outcomes (4)

  • Duration of hospitalization

    Date hospital discharge (expected maximum of 5 days)

  • Blood pressure

    Day 0 (within 1 hour preceding a coronography)

  • Cardiac frequency (beats per minute)

    Day 0 (within 1 hour preceding a coronography)

  • Visual analog scale for satisfaction concerning care

    Day 0 (within 1 hour preceding a coronography)

Study Arms (2)

Standard Care

OTHER

Patients randomized to this arm will have standard care with no extra interventions. Intervention: Inclusion visit Intervention: Coronarography on day 0

Other: Inclusion visitProcedure: Coronarography on day 0

HEARTLINK

EXPERIMENTAL

Patients randomized to this arm will participate in the HEARTLINK program, which includes a specific nurse consultation and telephone contact. Intervention: Inclusion visit Intervention: Nurse consultation Intervention: Telephone contact Intervention: Coronarography on day 0

Other: Inclusion visitOther: Nurse consultationOther: Telephone contactProcedure: Coronarography on day 0

Interventions

Inclusion visitOTHER

This visit takes place between days -15 and -7 preceding a coronarography scheduled for Day 0. It is part of standard care and corresponds to a required cardiology consultation.

HEARTLINKStandard Care
Nurse consultationOTHER

This visit takes place on the same day as the inclusion visit and includes practical advice concerning the hospital stay, explanations concerning the surgical act and practical advice on its implementation, information on the length of stay and after. An explanatory booklet concerning the surgical procedure is provided to the patient.

HEARTLINK
Telephone contactOTHER

A nurse will telephone the patient 72h to 48h before the coronarography scheduled for day 0. During the telephone conversation the nurse will assess the patient's knowledge about his/her pathology, his/her examination and the course of hospitalization. The nurse will answer any questions and if needed provide further information.

HEARTLINK
Coronarography on day 0PROCEDURE

This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.

HEARTLINKStandard Care

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient for whom elective coronary angiography is indicated
  • The patient has never had a coronary angiography before

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant or breastfeeding
  • The subject has already had a coronary angiography
  • The subject has a cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Study Officials

  • Eric Baljou, IDE

    Centre Hospitalier Universitaire de Nîmes

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 18, 2016

Study Start

November 19, 2019

Primary Completion

May 10, 2022

Study Completion

May 10, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

FR(1)