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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06068725
Other study ID # EU-NF-PY-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date September 15, 2023

Study information

Verified date September 2023
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date September 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Training videos
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).

Locations

Country Name City State
Turkey Dr. Sadi Konuk Training and Research Hospita Istanbul
Turkey Istanbul Yeni Yüzyil University Private Gaziosmanpasa Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Three months
Secondary 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 Three months
Secondary 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. Three months
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