NCT05631340

Brief Summary

This study aims to build a new discharge education, booklet and mobile application based, and assess it's efffects on recovery and quality of life in cardiac surgery patients. This is a randomised control trial. 12 weeks follow up will be done by phone calls.

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
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

November 21, 2022

Last Update Submit

November 21, 2022

Conditions

Keywords

Cardiac Surgery, Heart Surgery, Discharge Education, Nursing, Telenursing, m-Health, Quality of Life, Recovery

Outcome Measures

Primary Outcomes (2)

  • Recovery status after cardiac surgery

    Recovery -40 Questionnaire mesure recovery status before discharge and 12 weeks after discharge

    12 weeks

  • Quality of Life after cardiac surgery

    Multidimensional Index of Life Quality questionnaire to mesure QoL before discharge and 12 weeks after discharge

    12 weeks

Study Arms (2)

case group

EXPERIMENTAL

Recieving additional discharge education by the researcher and supported by a booklet and mobile app

Other: Discharge education

control group

ACTIVE COMPARATOR

Recieving standart hoapital discharge education

Other: Discharge education

Interventions

Researcher's newly prepared discharge education supported by a booklet and mobile app

case groupcontrol group

Eligibility Criteria

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

You may qualify if:

  • To agree to participate in the research,
  • Open heart surgery patients
  • Being 18 years or older,
  • Being able to read, write, understand and communicate in Turkish,
  • No vision, hearing and perception problems,
  • Being conscious, oriented, cooperative and open to communication.

You may not qualify if:

  • Having surgery other than open heart surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Univesity-Cerrahpasa Florence Nightingale Faculty of Nursing

Istanbul, Şişli, 34000, Turkey (Türkiye)

RECRUITING

Study Officials

  • Ayfer Özbaş

    Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants do not know the group they belong, case or control
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: same follow up time
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 21, 2022

First Posted

November 30, 2022

Study Start

April 1, 2022

Primary Completion

November 18, 2022

Study Completion

June 30, 2023

Last Updated

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Research data will be given statistically without sharing IPD

Locations