NCT01988064

Brief Summary

The aim of this study is to compare the efficacy of group training using a tutorial film and one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in the pulse rhythm in patients with cardiovascular diseases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

November 4, 2013

Last Update Submit

November 13, 2013

Conditions

Arrythmia

Keywords

pulse ratepatient educationtraining

Outcome Measures

Primary Outcomes (1)

  • Ability to calculated the pulse rate correctly and detected pulse irregularity

    The number of participants who can calculate the pulse rate correctly and detect pulse irregularity, and the participants' improvement in the ability to calculated the pulse rate correctly and detected pulse irregularity on the three time points, will be compared between the two groups.

    The outcome will be measured on three distinct time points; before the training session(base line), right after the training session, and at least 48 hours after the training session

Study Arms (2)

Face-to-face training

EXPERIMENTAL

One-to-one face-to-face training on calculating the pulse rate and detecting pulse abnormalities performed by the nurse.

Other: Face-to-face training

Group training

EXPERIMENTAL

Group training using a tutorial film on calculating the pulse rate and detecting pulse abnormalities.

Other: Group training

Interventions

Face-to-face trainingOTHER

One-to-one face-to-face training on calculating the pulse rate and detecting abnormalities.

Face-to-face training
Group trainingOTHER

Group training using a tutorial film on calculating the pulse rate and detecting abnormalities.

Group training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted in cardiology ward
  • Literacy (ability to read and write)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular research center, Modarres hospital.

Tehran, Tehran Province, Iran

RECRUITING

Related Publications (3)

  • Munschauer FE 3rd, Sohocki D, Smith Carrow S, Priore RL. A community education program on atrial fibrillation: implications of pulse self-examination on awareness and behavior. J Stroke Cerebrovasc Dis. 2004 Sep-Oct;13(5):208-13. doi: 10.1016/j.jstrokecerebrovasdis.2004.08.001.

    PMID: 17903977BACKGROUND

  • Hwu YJ, Coates VE, Lin FY. A study of the effectiveness of different measuring times and counting methods of human radial pulse rates. J Clin Nurs. 2000 Jan;9(1):146-52. doi: 10.1046/j.1365-2702.2000.00350.x.

    PMID: 11022503BACKGROUND

  • Breckwoldt J, Schloesser S, Arntz HR. Perceptions of collapse and assessment of cardiac arrest by bystanders of out-of-hospital cardiac arrest (OOHCA). Resuscitation. 2009 Oct;80(10):1108-13. doi: 10.1016/j.resuscitation.2009.06.028. Epub 2009 Jul 25.

    PMID: 19632755BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Habibolah Saadat, Professor of cardiology

    Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alipour Parsa S., Assistant professor of cardiology, Cardiovascular Research Center, Modarres hospital

Study Record Dates

First Submitted

November 4, 2013

First Posted

November 20, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

IR(1)