NCT06192290

Brief Summary

The main aim is to determine the impact of home video-based cardiac rehabilitation program on elderly patients' health-related quality of life and therapeutic self-care post-coronary revascularization

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
118

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2021

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

December 31, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

1.7 years

First QC Date

December 19, 2023

Last Update Submit

January 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Coronary revascularization outcome questionnaire (CROQ)- CROQ-CABG version

    Developed by schroter S and Lamping DL (2004) (34) to be the only practical and scientifically validated patient-based measure of outcome for coronary revascularization that is acceptable to patients, the only tool that includes psychosocial and cognitive functioning as well as surgery-specific items, and satisfies rigorous psychometric criteria for reliability, validity, and responsiveness. This validated instrument developed specifically for use before and after CABG and PTCA, which is quick and easy to administer and provides more appropriate content as it contains items directly addressing the impact of these procedures based on problems that patients reported to be important.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • The Sidani Doran Therapeutic Self-Care Measure (SDTSCM) -The Home Setting care Version

    through study completion, an average of 1 year

Study Arms (2)

Control Group

NO INTERVENTION

(1) aged 60 years or older; (2) diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist; (3) intact cognitive function; (4) agree to be visited by the researchers at home; and (5) didn't have previous experiences with CABG. These Patients receive the usual care only.

Intervention Group

EXPERIMENTAL

(1) aged 60 years or older; (2) diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist; (3) intact cognitive function; (4) agree to be visited by the researchers at home; and (5) didn't have previous experiences with CABG. These Patients will receive the Video film presentations and content (16 parts)

Behavioral: Home-based transitional Cardiac Telerehabilitation

Interventions

This comprehensive series is divided into 16 parts, each addressing crucial aspects of open-heart surgery recovery. Part 1 introduces open-heart surgery, heart disease symptoms, and preoperative preparations for elderly patients. Part 2 delves into cardiac rehabilitation, defining objectives and detailing recovery stages. Part 3 covers care for surgical incisions and infection signs. Part 4 explores sleep and rest, while Part 5 guides patients on a healthy post-surgery diet. Part 6 focuses on nursing interventions for dyspnea, and Part 7 addresses post-surgery cough. Part 8 discusses nursing interventions for thrombosis prevention

Intervention Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 60 years or older
  • diagnosed with CAD and were recommended to undergo elective CABG by a cardiologist
  • intact cognitive function
  • agree to be visited by the researchers at home
  • didn't have previous experiences with CABG.

You may not qualify if:

  • Have an experience with CABG
  • demonstrates cognitive dysfunctions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shark El-Madinah Hospital, the Secretariat of Specialized Medical Centers (Cardiothoracic Surgery Department and Intensive Care Unit)

Alexandria, Egypt

RECRUITING

Related Publications (4)

  • Ghisi GL, Grace SL, Thomas S, Oh P. Behavior determinants among cardiac rehabilitation patients receiving educational interventions: an application of the health action process approach. Patient Educ Couns. 2015 May;98(5):612-21. doi: 10.1016/j.pec.2015.01.006. Epub 2015 Jan 20.

  • Fosbol EL, Zhao Y, Shahian DM, Grover FL, Edwards FH, Peterson ED. Repeat coronary revascularization after coronary artery bypass surgery in older adults: the Society of Thoracic Surgeons' national experience, 1991-2007. Circulation. 2013 Apr 23;127(16):1656-63. doi: 10.1161/CIRCULATIONAHA.113.001882. Epub 2013 Mar 26.

  • Osailan A, Abdelbasset WK. Exercise-based cardiac rehabilitation for postcoronary artery bypass grafting and its effect on hemodynamic responses and functional capacity evaluated using the Incremental Shuttle Walking Test: A retrospective pilot analysis. J Saudi Heart Assoc. 2020 Apr 17;32(1):25-33. doi: 10.37616/2212-5043.1005. eCollection 2020.

  • Lim SK, Han JY, Choe YR. Comparison of the Effects of Cardiac Rehabilitation Between Obese and Non-obese Patients After Acute Myocardial Infarction. Ann Rehabil Med. 2016 Oct;40(5):924-932. doi: 10.5535/arm.2016.40.5.924. Epub 2016 Oct 31.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Ahmed H El-Monshed, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

December 31, 2021

Primary Completion

September 1, 2023

Study Completion

February 1, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations