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

NCT05418478 | Active Not Recruiting

• 1 other identifier: 46811200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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''.

Conditions

Heart Failure

Keywords

Heart Failure; Transtheoretic model; Treatment Compliance; Self-care; Tele-health; Patient education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Medication Compliance Notification Scale

  Baseline-6 months

• Minnesota Life with Heart Failure Survey

  Baseline-6 months

• New York Heart Association classification (NYHA)

  Baseline-6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Study group intervention: 7 sessions of transtheoretical model-based interview (2 in the first month, a total of 7 times, once a month), a structured disease education through transtheoretical model-based telehealth practices, and 6-month follow-up. * After the participants are included in the study, a health education structured according to the Transtheoretical model will be given to the patients in the study group through tele-health applications. * 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 first month and once a month in the following months. Tele-health applications include phone monitoring, SMS notification and application applications. * In the 6-month follow-up, there will be 2 follow-ups as pre-test (1st month) and post-test (6th month). * Behavioral: 7 sessions of behavior change training based on the transtoerytic model

Behavioral: Intervention transtheoretical model group

Control

NO INTERVENTION

* No notification will be made to the relatives of the patients in the control group. Control group patients will be called for routine control in line with their usual plans. After a total of 6 months from the beginning, the self-care and treatment compliance levels of the patients in the control group will be examined. * There will be 2 follow-ups as pre-test (1st month) and post-test (6th month).

Interventions

Intervention transtheoretical model group BEHAVIORAL

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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with communication difficulties
• Patients who cannot use tele-health applications

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran University

Sanliurfa, Türki̇ye, 63000, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 25520374 BACKGROUND

• 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.

  PMID: 30128093 BACKGROUND

• 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.

  PMID: 18055007 BACKGROUND

• 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.

  PMID: 32202313 BACKGROUND

• 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.

  PMID: 28858886 RESULT

• 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.

  PMID: 20168193 RESULT

• 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.

  PMID: 31174893 RESULT

• 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.

  PMID: 26743119 RESULT

MeSH Terms

Conditions

Heart Failure; Patient Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• İbrahim C Di̇ki̇ci̇, MSc

  Harran Üniversitesi

  STUDY DIRECTOR

• Medet Korkmaz, PhD

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 14, 2022
• Study Start: June 7, 2022
• Primary Completion: January 10, 2023
• Study Completion: September 10, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)