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RecruitingNCT06192290Updated Jan 5, 2024

Home-based Transitional Telerehabilitation in Cardiac Recovery

An interventional study of Home-based transitional Cardiac Telerehabilitation in Coronary Artery Disease and Cardiac Rehabilitation, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Dec 2021, registered Dec 2023).
  • Started Dec 2021; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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

Read the detailed description

Over the past decade, the efficacy of coronary artery bypass graft (CABG) surgery in treating coronary artery disease (CAD) has significantly advanced, particularly in improving symptom relief and survival rates among older adults. Remarkably, CAD stands as the foremost cause of global mortality, contributing to a staggering 16% of all deaths, with a notable surge of more than 2 million additional fatalities recorded in 2019, reaching a total of 8.9 million. This escalating incidence is particularly pronounced in the Middle East and North Africa, where CAD has witnessed a 160% increase, signifying a critical healthcare concern with a mortality rate of 120 per 100,000 individuals.

In the realm of cardiovascular diseases, individuals aged 75 years and above face substantial threats, with CAD posing a significant threat to both morbidity and mortality. Despite the acknowledged benefits of CABG, older adults' post-CABG commonly grapple with a spectrum of musculoskeletal and neurological challenges stemming from the surgical procedure. This encompasses incisional sternotomy pain, respiratory issues, weakness, leg swelling, sleeping difficulties, wound healing complications, poor appetite, dissatisfaction with postoperative supportive care, and difficulties with eating. Psycho-socially, these individuals often experience distress, depression, a sense of loss of control, concerns about surgery success, social dysfunction, and fear of death.

The postoperative period necessitates an in-hospital stay of approximately one week, with depressed functional capacity immediately following CABG, potentially linked to fear of activity and pain exacerbated by movement. This is followed by a convalescence period of 2 to 6 weeks for recovery after discharge and the resumption of daily activities. The healing process for chest and leg wounds typically spans 4 to 6 weeks, with pulmonary function and lung capacity decreasing one week following CABG up to 4-6 months after surgery compared to pre-surgery levels.

02

Conditions studied

  • Coronary Artery Disease
  • Cardiac Rehabilitation
03

In context

Coronary Artery Disease

5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 118 is close to the median of 123 across 3,438 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 182 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Have an experience with CABG
  • demonstrates cognitive dysfunctions.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
118 participants (estimated)

Study arms

  • No intervention
    Control Group

    (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.

  • Experimental
    Intervention Group

    (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

  • BehavioralHome-based transitional Cardiac Telerehabilitation

    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

06

What researchers measure

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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

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

    Developed by Sidani and Doran (2001) \& (2002) (35,36). to measure the action taken by a patient to promote, maintain or improve health, prevent sickness, detect and manage symptoms, and regain normal functioning. This 12-item scale measures a person's ability to perform activities that are directed at maintaining health, managing health, and restoring function (37). Patients were asked to rate their ability to perform self-care activities when home (38), with a 6-point numeric rating scale anchored with "not at all (0)" and "very much (5)".

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Shark El-Madinah Hospital, the Secretariat of Specialized Medical Centers (Cardiothoracic Surgery Department and Intensive Care Unit)
    Alexandria, Egypt
    • Camellia Sami · Contact · +203-5506222
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25638305 ↗
  • 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. PubMed 23532630 ↗
  • 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. PubMed 33154888 ↗
  • 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. PubMed 27847723 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06192290
Lead sponsor
Mansoura University
Responsible party
Ahmed Hashem El-Monshed (Associate Professor, Mansoura University) — Principal investigator
First posted
Jan 5, 2024
Start date
Dec 31, 2021
Primary completion
Sep 1, 2023
Completion
Feb 1, 2024 (estimated)
Last update
Jan 5, 2024

Study contacts

Ahmed H El-Monshed, Ph.D
Contact
ahmed_elmonshed@mans.edu.eg
+97334046945
Marwa Mahfouz, Ph.D
Contact
marwa-mahfouz@alexu.edu.eg
+20 127 020 2044

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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