The Effect of Video Training o Symptom Management With Heart Failure

NCT06068725 | Completed

• 1 other identifier: EU-NF-PY-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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?

Conditions

Heart Failure

Keywords

Quality of Life; Geriatrics; Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Minnesota Living with Heart Failure Questionnaire

  Three months

• Michel Uncertainty in Illness Scale - Society Form

  Three months

Study Arms (2)

No invention: Control Group

NO INTERVENTION

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.

Experimental: application group

EXPERIMENTAL

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.

Behavioral: Training videos

Interventions

Training videos BEHAVIORAL

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).

Experimental: application group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 65 years of age
• Known serious vision and hearing problems
• With cognitive impairment

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Dr. Sadi Konuk Training and Research Hospita

Istanbul, Turkey (Türkiye)

Location

Istanbul Yeni Yüzyıl University Private Gaziosmanpaşa Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pinar YEL

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: It consists of two groups, application and control, and three follow-ups.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 5, 2023
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 15, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)