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Coronary Artery DiseaseNCT06192290

Home-based Transitional Telerehabilitation in Cardiac Recovery

A study testing Home-based transitional Cardiac Telerehabilitation in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Home-based transitional Cardiac Telerehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteEgypt
Study dates
31 Dec 2021to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Have an experience with CABG
  • demonstrates cognitive dysfunctions.

Trial locations and contacts

1 site in 1 country.

Ahmed H El-Monshed, Ph.D contact

+97334046945

ahmed_elmonshed@mans.edu.eg

Marwa Mahfouz, Ph.D contact

+20 127 020 2044

marwa-mahfouz@alexu.edu.eg

Egypt1 site, 1 recruiting

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

    Alexandria

    Camellia Sami, +203-5506222

    Recruiting

Other trials in Egypt

About this study

Official title: Home-based Transitional Telerehabilitation in Cardiac Recovery: A Study on the Health-Related Quality of Life and Therapeutic Self-Care in Older Adults Post Coronary Artery Bypass Grafting

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.

Being tested
Home-based transitional Cardiac Telerehabilitation
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based transitional Cardiac TelerehabilitationBehavioural

    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

Study groups in NCT06192290
Study groupRoleWhat they receive
Control GroupNo 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 GroupExperimental(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)
Receives: Behavioral: Home-based transitional Cardiac Telerehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  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)".

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start31 Dec 2021
  3. Primary completion1 Sep 2023
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192290
Sponsor's protocol ID
Home-based TT in Cardiac Rec.
Status last verified
Jan 2024
First submitted
19 Dec 2023
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

  • Mahfouz Khalil MI, El-Monshed AH, Shaala RS, El-Sherif SM, Mousa EFS. Home-based transitional cardiac telerehabilitation in older adults post coronary artery bypass grafting: A randomized controlled trial. Geriatr Nurs. 2024 Sep-Oct;59:139-149. doi: 10.1016/j.gerinurse.2024.06.044. Epub 2024 Jul 13.

    PubMed 39002504

Questions about this trial

What is this clinical trial studying?

A study testing Home-based transitional Cardiac Telerehabilitation in people with Coronary Artery Disease and Cardiac Rehabilitation, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed H El-Monshed, Ph.D (+97334046945, ahmed_elmonshed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary revascularization outcome questionnaire (CROQ)- CROQ-CABG version (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06192290, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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