The Effect of Education Given to Patients With Heart Failure on Self-care, Drug Compliance and Quality of Life.

Heart Failure Clinical Trial

Official title:

The Effect of Training Given to Patients With Heart Failure Through Transtheoretic Model-based Telehealth Methods on Self-care, Drug Adherence and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418478
• Other study ID #: 46811200
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: February 10, 2024

Study information

• Verified date: July 2023
• Source: Harran University
• Contact: Ibrahim C Di?ki?ci?, MSc
• Phone: +905376729057
• Email: ibrahimcanerdikici[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned as a randomized, controlled, experimental study to evaluate the effects of transtheoretic model-based education on self-care, drug compliance and quality of life in patients with heart failure. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses in follow-up and considering that non-parametric tests can be performed, the research group will consist of a total of 72 people, 36 in each group, with an increase of 20%. Patients with heart failure who do not have communication barriers to affect cognitive functions, can use tele-health applications (Smartphone and application), volunteers aged 18 and over and agree to participate in the study will be included in the intervention and control groups. The data of the study, "Socio-demographic Characteristic Data Form", "Question Form Regarding the Disease", "European Heart Failure Self-Care Behaviors Scale-12", "Beliefs About Medication Adherence Scale," in which socio-demographic characteristics and information about the disease were questioned. (IUHIO)'' and ''Minnesota Life with Heart Failure Questionnaire''.

Description:

The patients in the intervention group will be trained through tele-health practices for at least 25-30 minutes on a transtheoretical basis, every 2 weeks in the 1st month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications. Educational topics based on model-based self-care behaviors; It will include regular exercise, nutrition-weight monitoring, fluid intake-edema control, smoking cessation, regular drug use, regular rest, vaccination. Educational principles will be shared with patients by SMS from time to time during the education process. Treatment compliance levels and self-care behaviors of both groups of patients will be re-measured from the first week to the 6th month after the training, and any difference will be analyzed using statistical methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 10, 2024
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have no communication barriers to affect cognitive functions,

• Ejection-Fraction over 20

• Diagnosed with Heart Failure for at least 6 months

• Able to use tele-health applications (smartphone and application)

Exclusion Criteria:

• Patients with communication difficulties

• Patients who cannot use tele-health applications

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Intervention transtheoretical model group
The Transtheoretical Model is a conscious behavior modification model that focuses on individual decision making and planning processes. It is the only model that examines behavior change as a dynamic process rather than an outcome, and considers behavioral strategies that include the individual's cognitive and behavioral processes in this process. In the model, it is stated that behavior change is a process and develops gradually. It is reported that the change in the behavior of individuals consists of six stages: 1) not thinking, 2) thinking, 3) preparation, 4) taking action, 5) maintaining and 6) terminating. This model consists of four main constructs called change stages (time-related dimension), change processes/behavior modification methods (independent variable dimension), self-efficacy (levels of change) and decision-making balance (perceptions of harm and benefit of change).

Locations

Country	Name	City	State
Turkey	Harran University	Sanliurfa	Türki?ye

Sponsors (1)

Lead Sponsor	Collaborator
Harran University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Abbasi A, Ghezeljeh TN, Farahani MA. Effect of the self-management education program on the quality of life in people with chronic heart failure: a randomized controlled trial. Electron Physician. 2018 Jul 25;10(7):7028-7037. doi: 10.19082/7028. eCollection 2018 Jul. — View Citation

Chen H, Wang Y, Liu C, Lu H, Liu N, Yu F, Wan Q, Chen J, Shang S. Benefits of a transtheoretical model-based program on exercise adherence in older adults with knee osteoarthritis: A cluster randomized controlled trial. J Adv Nurs. 2020 Jul;76(7):1765-1779. doi: 10.1111/jan.14363. Epub 2020 May 13. Erratum In: J Adv Nurs. 2022 Jun;78(6):1849. — View Citation

Johnson SS, Paiva AL, Cummins CO, Johnson JL, Dyment SJ, Wright JA, Prochaska JO, Prochaska JM, Sherman K. Transtheoretical model-based multiple behavior intervention for weight management: effectiveness on a population basis. Prev Med. 2008 Mar;46(3):238-46. doi: 10.1016/j.ypmed.2007.09.010. Epub 2007 Oct 23. — View Citation

Lee S, Riegel B. State of the Science in Heart Failure Symptom Perception Research: An Integrative Review. J Cardiovasc Nurs. 2018 May/Jun;33(3):204-210. doi: 10.1097/JCN.0000000000000445. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. Erratum In: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417. — View Citation

Paradis V, Cossette S, Frasure-Smith N, Heppell S, Guertin MC. The efficacy of a motivational nursing intervention based on the stages of change on self-care in heart failure patients. J Cardiovasc Nurs. 2010 Mar-Apr;25(2):130-41. doi: 10.1097/JCN.0b013e3 — View Citation

Reid KRY, Reid K, Esquivel JH, Thomas SC, Rovnyak V, Hinton I, Campbell C. Using video education to improve outcomes in heart failure. Heart Lung. 2019 Sep-Oct;48(5):386-394. doi: 10.1016/j.hrtlng.2019.05.004. Epub 2019 Jun 4. — View Citation

Riegel B, Masterson Creber R, Hill J, Chittams J, Hoke L. Effectiveness of Motivational Interviewing in Decreasing Hospital Readmission in Adults With Heart Failure and Multimorbidity. Clin Nurs Res. 2016 Aug;25(4):362-77. doi: 10.1177/1054773815623252. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Heart Failure Self-Care Behaviors Scale	The scale includes recognizing symptoms such as edema and weight gain, dyspnea, and fatigue associated with heart failure; It consists of 12 questions to measure self-care behaviors such as applying to a doctor and nurse for these symptoms, regular use of drugs, use of fluid and salt, treatment such as diet and exercise regimen and self-care behaviors such as weight monitoring and edema monitoring.	Baseline-6 months
Secondary	Medication Compliance Notification Scale	The total test score is obtained by summing the scores obtained from the scale items evaluating drug compliance. Scores from the scale range from 5 to 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates inconsistency.	Baseline-6 months
Secondary	Minnesota Life with Heart Failure Survey	The scale measures the effect of physical and social functionality on heart failure, as well as assessing the effect of common physical symptoms such as shortness of breath, fatigue, peripheral edema, anxiety and depression symptoms. The 21-item scale is in a six-point Likert type (never=0, very little=1, little=2, a little=3, a lot=4, a lot=5). The lowest score that can be obtained from the scale is 0, and the highest score is 105.	Baseline-6 months
Secondary	New York Heart Association classification (NYHA)	Classification of the clinical picture according to the functional status of the patients, from 1 to 4, patients are classified according to their physical activities.	Baseline-6 months