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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04245020
Other study ID # ISOTOPE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2019
Est. completion date June 21, 2020

Study information

Verified date April 2021
Source Connolly Hospital Blanchardstown
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Data will be collected to identify complications identified in each arm along with the rate of non-response to the follow up methods and the level of satisfaction with the method. Willingness to use a telemedicine app in the future will also be evaluated through satisfaction survey.


Description:

This is a non-blinded, single centre open randomised control trial of the outpatient follow up method following surgical admission to Connolly Hospital Blanchardstown. All eligible patients will be randomised into three arms, text message, telephone or in-person follow up. The follow up will be carried out at 6-8 weeks following discharge. The rate of complications, the non-response rate and the level of satisfaction will be compared between the three groups. Willingness to use a telemedicine app in the future in place of an in-person follow up will also be measured by patient satisfaction questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date June 21, 2020
Est. primary completion date June 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Surgical patients admitted either as an emergency or for an elective procedure - 16 years or older Exclusion Criteria: - Did not consent or cannot give consent - Age less than 16 - No smartphone - Further follow up required for treatment of further investigation - Diagnosis or suspected diagnosis of malignancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Text message follow up
A text message will be sent to the patient 6-8 weeks following discharge
Telephone follow up
The patient will be followed up at 6-8 weeks following discharge with a telephone call
In person follow up
The patient will be followed up at 6-8 weeks following discharge in person in the outpatient department

Locations

Country Name City State
Ireland Connolly Hospital Blanchardstown Dublin 15 Co. Dublin

Sponsors (1)

Lead Sponsor Collaborator
Connolly Hospital Blanchardstown

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complications that require further follow up Complications are identified by patient record and follow up method selected 6-8 weeks
Secondary Satisfaction in follow up A questionnaire will assess how happy based on a survey patients were with their follow up method. The CSQ 8 score will be used along with a previously published questionnaire from this institiution. In the CSQ-8 questionnaire a higher score indicates more satisfaction. 8-10 weeks
Secondary Willingness to use a virtual clinic app in the future A questionnaire will assess patients preference in further follow up, specifically are patients happy to use a telemedicine based app. (answer no definitely not, no not really, yes generally, yes definitely. 8-10 weeks
Secondary Follow up preference Preferred follow up method will be identified by above patient questionnaire (text, phone or OPD) 8-10 weeks
Secondary Lost to follow up number of patients that are lost to follow up per follow up method 6-8 weeks
Secondary Further procedures arranged number of patients who have an additional procedure arranged which will be identified in the medical record 8-10 weeks
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