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The Effect of Video Training o Symptom Management With Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Training videos
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Quality of Life, Geriatrics, Nursing

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 65 years and above Volunteer to participate in the research Diagnosed with heart failure at least six months ago He/she/his relative has internet access and can use a smartphone Digital literacy scale score over 17 Class I, II, III according to NYHA classification Exclusion Criteria: Under 65 years of age Known serious vision and hearing problems With cognitive impairment

Sites / Locations

  • Dr. Sadi Konuk Training and Research Hospita
  • Istanbul Yeni Yüzyıl University Private Gaziosmanpaşa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No invention: Control Group

Experimental: application group

Arm Description

Data collection tools were applied to individuals in the control group on day 0 (Z0), day 30 (Z1) and day 90 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire,Michel Uncertainty in Illness Scale - Community Form.

Two 15-minute training videos (30 minutes in total) prepared for symptom management will be shared on the phones of the patients/relatives in the application group and the patients and their relatives will be informed by watching the training video.Data collection tools were applied to individuals in the application group on day 0 (Z0), day 30 (Z1) and day 90 (Z2) of follow-up. Data collection tools applied to the application group are as follows: Patient Introduction Form, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire,Michel Uncertainty in Illness Scale - Community Form.

Outcomes

Primary Outcome Measures

Heart Failure Symptom Status Scale
It measures the presence, frequency and severity of seven basic symptoms, such as dyspnea during the day, dyspnea when lying down, fatigue, chest pain, edema, sleep problems, dizziness or dizziness, which are the most common in heart failure patients, and the degree to which each of these symptoms affects the patient.When the patient expresses the "zero" option, this indicates that the patient does not have the relevant symptom. To calculate each symptom, all values given by patients for frequency, severity and discomfort are added together. The scores that can be obtained from the scale vary between 0-84.

Secondary Outcome Measures

Minnesota Living with Heart Failure Questionnaire
Disease-specific heart failure and its treatment in patients' lives; It evaluates its effects and perceptions in physical, socio-economic and psychological dimensions.The total score on the scale varies between 0-105. A low score on the scale indicates a high quality of life
Michel Uncertainty in Illness Scale - Society Form
The scale reveals the uncertainty experienced by individuals with chronic diseases during periods when they are not hospitalized. The Turkish version of the scale consists of 20 items. The scale is evaluated through three sub-dimensions and a total score: "perception of the current situation", "perception of understanding" and "uncertainty".The score that can be obtained from the scale varies between 20 and 100, with the average being 60. An increase in the score obtained from the scale is interpreted as an increase in disease uncertainty.

Full Information

First Posted
September 29, 2023
Last Updated
September 29, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT06068725
Brief Title
The Effect of Video Training o Symptom Management With Heart Failure
Official Title
T The Effect Of Video Training On Symptom Management And Quality Of Life In Patients Over 65 Years Of Age Wıth Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege 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
The purpose of this clinical study is to compare the effect of video-assisted training on the quality of life and symptom management of patients over the age of 65. The main questions it aims to answer are: -Is there a difference between symptom management and quality of life between the first and last follow-up periods of patients in the application and control groups?
Detailed Description
Heart failure is the primary disease of old age. 20% of the reasons for hospital admission for patients aged 65 and over are due to heart failure.The most common symptoms in patients with heart failure are; fatigue, weakness, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, edema and changes in mental status.Due to these physical symptoms; there is a decrease in the functional capacity of patients, difficulty in performing daily life activities, inability to perform self-care, and the incidence of depression and anxiety increases. In symptom management of patients with heart failure; these include knowing the clinical course of the disease, adapting to the disease and treatment, monitoring symptoms, educating the patient on self-care, and regular follow-up after discharge.It is stated that with patient education given to individuals in a planned and regular manner, the frequency and severity of the symptoms experienced decreases, the management and control of the disease is ensured, and thus the patient's quality of life is increased by creating the necessary behavioral changes.Due to the increase in the number of internet users in patient education, web-based education becomes more prominent.Thanks to video training, patients will be able to experience a permanent learning process by accessing the training content wherever they want, as often as they want.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Quality of Life, Geriatrics, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It consists of two groups, application and control, and three follow-ups.
Masking
ParticipantOutcomes Assessor
Masking Description
In the study, groups were determined by block randomization. The randomization list was created by block randomization according to New York Heart Association (NYHA) classification.
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No invention: Control Group
Arm Type
No Intervention
Arm Description
Data collection tools were applied to individuals in the control group on day 0 (Z0), day 30 (Z1) and day 90 (Z2) of follow-up. Data collection tools applied to the control group are as follows: Patient Introduction Form, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire,Michel Uncertainty in Illness Scale - Community Form.
Arm Title
Experimental: application group
Arm Type
Experimental
Arm Description
Two 15-minute training videos (30 minutes in total) prepared for symptom management will be shared on the phones of the patients/relatives in the application group and the patients and their relatives will be informed by watching the training video.Data collection tools were applied to individuals in the application group on day 0 (Z0), day 30 (Z1) and day 90 (Z2) of follow-up. Data collection tools applied to the application group are as follows: Patient Introduction Form, Heart Failure Symptom Status Scale, Minnesota Living with Heart Failure Questionnaire,Michel Uncertainty in Illness Scale - Community Form.
Intervention Type
Behavioral
Intervention Name(s)
Training videos
Intervention Description
After determining the application and control groups in the research, the purpose of the research was explained to both groups. The mobile phone usage skills of the individuals who will be included in the application group were evaluated with the Digital Literacy Scale. Training videos for 15 people each (30 minutes in total) regarding symptom management were shared on the phones of the patients/relatives in the application groups, and the patients and their relatives were informed and watched the training video. Data collection forms would be filled out before the application (Z0), on the 30th day of the application (Z1), and on the 90th day of the application (Z2).
Primary Outcome Measure Information:
Title
Heart Failure Symptom Status Scale
Description
It measures the presence, frequency and severity of seven basic symptoms, such as dyspnea during the day, dyspnea when lying down, fatigue, chest pain, edema, sleep problems, dizziness or dizziness, which are the most common in heart failure patients, and the degree to which each of these symptoms affects the patient.When the patient expresses the "zero" option, this indicates that the patient does not have the relevant symptom. To calculate each symptom, all values given by patients for frequency, severity and discomfort are added together. The scores that can be obtained from the scale vary between 0-84.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Minnesota Living with Heart Failure Questionnaire
Description
Disease-specific heart failure and its treatment in patients' lives; It evaluates its effects and perceptions in physical, socio-economic and psychological dimensions.The total score on the scale varies between 0-105. A low score on the scale indicates a high quality of life
Time Frame
Three months
Title
Michel Uncertainty in Illness Scale - Society Form
Description
The scale reveals the uncertainty experienced by individuals with chronic diseases during periods when they are not hospitalized. The Turkish version of the scale consists of 20 items. The scale is evaluated through three sub-dimensions and a total score: "perception of the current situation", "perception of understanding" and "uncertainty".The score that can be obtained from the scale varies between 20 and 100, with the average being 60. An increase in the score obtained from the scale is interpreted as an increase in disease uncertainty.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 years and above Volunteer to participate in the research Diagnosed with heart failure at least six months ago He/she/his relative has internet access and can use a smartphone Digital literacy scale score over 17 Class I, II, III according to NYHA classification Exclusion Criteria: Under 65 years of age Known serious vision and hearing problems With cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pinar YEL
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Sadi Konuk Training and Research Hospita
City
Istanbul
Country
Turkey
Facility Name
Istanbul Yeni Yüzyıl University Private Gaziosmanpaşa Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Video Training o Symptom Management With Heart Failure

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