Web-based nursing support for patients recovering from bypass surgery

ISRCTN ISRCTN13653455
DOI https://doi.org/10.1186/ISRCTN13653455
Secondary identifying numbers 2018PS110K
Submission date
21/11/2023
Registration date
23/11/2023
Last edited
14/03/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Coronary artery disease (CAD) patients who have undergone coronary artery bypass grafting (CABG) post-operation always suffer a long-term rehabilitative period accompanied by diverse psychological disorders, which negatively affect their prognosis. Therefore, this study aimed to evaluate the effect of a web-based Information-Knowledge-Attitude-Practice (WIKAP) continuous intervention on the psychological status, medical compliance, and quality of life (QoL) in CAD patients after CABG surgery.

Who can participate?
Coronary artery disease patients above the age of 18 years who have underwent coronary artery bypass grafting (CABG).

What does the study involve?
Coronary artery disease (CAD) patients undergone coronary artery bypass grafting (CABG) post-operation will be randomly divided into the Control and WIKAP group, and received conventional routine nursing care and web-based Information-Knowledge-Attitude-Practice (WIKAP) continuous nursing intervention for 12 months, respectively. During the 12-months intervention period, the anxiety and depression rates is measured by Hospital Anxiety and Depression Scale (HADS-A and HADS-D), the medical compliance is detected by Morishy’s medication adherence scale (MMAS-8), and the QoL is assessed by using 12-Item Short-Form Health Survey (SF-12) at the first day after discharge (M0), at 3rd-month (M3), 6th-month (M6), 9th-month (M9) and 12th-month (M12) follow-up time points. Besides the 12-months interventional period, the occurrence of major adverse cardiac and cerebrovascular events (MACCE) is analyzed by the Kaplan-Meier curve for another 24-month follow-up period without intervention.

What are the possible benefits and risks of participating?
The participants who receive the web-based Information-Knowledge-Attitude-Practice (WIKAP) continuous nursing intervention may experience an improvement on their psychological health, medical compliance, quality of life, and a reduction of the occurrence of major adverse cardiac and cerebrovascular events (MACCE). However, these benefits are not guaranteed and may differ to a great extent depending on personal and social characteristics. Participation in the study does not have any potential risk.

Where is the study run from?
Shengjing Hospital Affiliated to China Medical University (China)

When is the study starting and how long is it expected to run for?
January 2018 to June 2023

Who is funding the study?
Liaoning Provincial Natural Science Foundation Program Project (China)

Who is the main contact?
Yan Jiang, yanjiangicu@163.com

Contact information

Dr Yan Jiang
Public, Scientific, Principal Investigator

No.36 Sanhao Street, Heping District
Shenyang
110004
China

ORCiD logoORCID ID 0009-0003-9829-7390
Phone +86-024-83955555
Email yanjiangicu@163.com

Study information

Study designInterventional randomized parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Home, Telephone
Study typeQuality of life, Efficacy
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleWeb-based continuous nursing intervention on the rehabilitation in patients with bypass grafting surgery
Study acronymWIKAP
Study objectivesWeb-based Information-Knowledge-Attitude-Practice continuous intervention would effectively improve the psychological health, medical compliance, and quality of life in patients undergone coronary artery bypass grafting operation.
Ethics approval(s)

Approved 04/01/2018, Research Ethics Committee of Shengjing Hospital Affiliated to China Medical University (36 Sanhao Rd, Heping District, Shenyang, 110004, China; +86-024-96615-10027 ; Meid_Zhang@163.com), ref: No.EC-2018-HS-117

Health condition(s) or problem(s) studiedOutcomes in patients that have undergone coronary artery bypass grafting operation.
InterventionRandomization Process:
1. Participant List Creation:
- Developed a comprehensive list encompassing all eligible cardiovascular disease patients who had undergone coronary artery bypass grafting, each assigned a distinct and unique identifier or number.
2. Random Selection Method:
- Employed a computer-generated random number generator to ensure an unbiased and impartial selection of participants for the study.
3. Group Assignment:
- Executed the allocation of participants into distinct groups based on the outcomes of the random assignment process.

Clinical Study Design:

Eligible patients, having undergone coronary artery bypass grafting, were systematically and randomly assigned to two groups in a 1:1 ratio:
1. Control Group:
- Participants in the control group received conventional routine nursing care over a 12-month period.
2. Experimental Group (WIKAP):
- In addition to routine nursing guidance, patients in the WIKAP group underwent a 12-month continuous nursing intervention focused on Web-based Information-Knowledge-Attitude-Practice (WIKAP).

Intervention Duration: 12 months

Throughout this 12-month intervention phase, various parameters were assessed at specific intervals:

- Anxiety and depression rates were measured using the Hospital Anxiety and Depression Scale (HADS-A and HADS-D).
- Medical compliance was evaluated through Morishy’s Medication Adherence Scale (MMAS-8).
- Quality of Life (QoL) was assessed using the 12-Item Short-Form Health Survey (SF-12) at distinct time points: the first day after discharge (M0), 3rd-month (M3), 6th-month (M6), 9th-month (M9), and 12th-month (M12) post-discharge.

Total Follow-up Period: 36 months

Beyond the initial 12-month interventional period, the occurrence of major adverse cardiac and cerebrovascular events (MACCE) was scrutinized using the Kaplan-Meier curve during an additional 24-month follow-up period without intervention.
Intervention typeBehavioural
Primary outcome measureMeasured using self report:
1. Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS)-A on the first day after discharge (M0), at 3rd-month (M3), 6th-month (M6), 9th-month (M9) and 12th-month (M12) after discharge.
2. Depression is measured using the Hospital Anxiety and Depression Scale (HADS)-D on the first day after discharge (M0), at 3rd-month (M3), 6th-month (M6), 9th-month (M9) and 12th-month (M12) after discharge.
3. Quality of life (QoL) is measured using the 12-Item Short-Form Health Survey (SF-12) on the first day after discharge (M0), at 3rd-month (M3), 6th-month (M6), 9th-month (M9) and 12th-month (M12) after discharge.
4. The occurrence of major adverse cardiac and cerebrovascular events (MACCE) is monitored and recorded within the whole 36-month follow-up period among all participants in this study.
Secondary outcome measuresThe medication compliance is measured using a Chinese version of Morishy’s Medication Adherence Scale (MMAS-8) on the first day after discharge (M0), at 3rd-month (M3), 6th-month (M6), 9th-month (M9) and 12th-month (M12) after discharge.
Overall study start date04/01/2018
Completion date10/06/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Total final enrolment174
Key inclusion criteria1. Diagnosed with cardiovascular diseases and underwent coronary artery bypass grafting operation surgery for the first time;
2. Patients or their direct caregivers were capable of using web-based social media (such as WeChat and QQ);
3. Age > 18 years old;
4. In good mental conditions and proper communication abilities;
5. Willing the taking part in this study voluntarily and sign the informed consent.
Key exclusion criteria1. Had cognitive or psychiatric disorders;
2. Combined with other severe organ dysfunctional disorders;
3. Unwilling to cooperate with researchers for any reason and refusal of continuing caring;
4. Lack of vision, speaking, reading and writing abilities;
5. The emergency of acute psychological or physical incidents;
6. Death after CABG operation
Date of first enrolment10/01/2018
Date of final enrolment10/12/2019

Locations

Countries of recruitment

  • China

Study participating centre

Shengjing Hospital Affiliated to China Medical University
No.36 Sanhao Street, Heping District
Shenyang
110004
China

Sponsor information

China Medical University
University/education

No. 77 Puhe Street, ShenBei New District
Shenyang
110122
China

Phone +86-024-31939080
Email kyc@cmu.edu.cn
Website http://www.cmu.edu.cn/eng/
ROR logo "ROR" https://ror.org/032d4f246

Funders

Funder type

Government

Liaoning Provincial Natural Science Foundation Program Project (China)

No information available

Results and Publications

Intention to publish date15/12/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planDataset will be available upon request from Yan Jiang (yanjiangicu@163.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 13/03/2024 14/03/2024 Yes No

Editorial Notes

14/03/2024: Publication reference added.
22/11/2023: Trial's existence confirmed by Research Ethics Committee of Shengjing Hospital Affiliated to China Medical University.