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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intervention transtheoretical model group
Sponsored by
Harran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Transtheoretic model, Treatment Compliance, Self-care, Tele-health, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Harran UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 31, 2022
Last Updated
July 27, 2023
Sponsor
Harran University
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1. Study Identification

Unique Protocol Identification Number
NCT05418478
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
February 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Transtheoretic model, Treatment Compliance, Self-care, Tele-health, Patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Intervention transtheoretical model group
Intervention Description
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).
Primary Outcome Measure Information:
Title
European Heart Failure Self-Care Behaviors Scale
Description
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.
Time Frame
Baseline-6 months
Secondary Outcome Measure Information:
Title
Medication Compliance Notification Scale
Description
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.
Time Frame
Baseline-6 months
Title
Minnesota Life with Heart Failure Survey
Description
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.
Time Frame
Baseline-6 months
Title
New York Heart Association classification (NYHA)
Description
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.
Time Frame
Baseline-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İbrahim C Di̇ki̇ci̇, MSc
Phone
+905376729057
Email
ibrahimcanerdikici@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Medet Korkmaz, PhD
Phone
+905065027980
Email
medetkorkmaz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İbrahim C Di̇ki̇ci̇, MSc
Organizational Affiliation
Harran Üniversitesi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Medet Korkmaz, PhD
Organizational Affiliation
Inonu University
Official's Role
Study Chair
Facility Information:
Facility Name
Harran University
City
Şanlıurfa
State/Province
Türki̇ye
ZIP/Postal Code
63000
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25520374
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.
Results Reference
background
PubMed Identifier
30128093
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.
Results Reference
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PubMed Identifier
18055007
Citation
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Results Reference
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PubMed Identifier
32202313
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.
Results Reference
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PubMed Identifier
28858886
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
result

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

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