Clinical trial NCT05418478: The Effect of Education Given to Patients With Heart Failure on Self-care, Drug Compliance and Quality of Life.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Transtheoretic model
Treatment Compliance
Self-care
Tele-health
Patient education
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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''.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: European Heart Failure Self-Care Behaviors Scale
timeFrame: Baseline-6 months
Secondary outcomes:
measure: Medication Compliance Notification Scale
timeFrame: Baseline-6 months
measure: Minnesota Life with Heart Failure Survey
timeFrame: Baseline-6 months
measure: New York Heart Association classification (NYHA)
timeFrame: Baseline-6 months
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University
state: Türki̇ye
Study officials:
affiliation: Harran Üniversitesi
name: İbrahim C Di̇ki̇ci̇, MSc
role: STUDY_DIRECTOR
affiliation: Inonu University
name: Medet Korkmaz, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.
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.
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.0b013e3181c52497.
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.
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. Epub 2016 Jan 6.