Heart FailureNCT06068725
The Effect of Video Training o Symptom Management With Heart Failure
A study testing Training videos in people with Heart Failure, run by Ege University at 2 sites in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Training videos
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Under 65 years of age
- Known serious vision and hearing problems
- With cognitive impairment
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dr. Sadi Konuk Training and Research Hospita
Istanbul
Istanbul Yeni Yüzyıl University Private Gaziosmanpaşa Hospital
Istanbul
About this study
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
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?
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Training videos
- Keywords
- Quality of Life, Geriatrics, Nursing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training videosBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Secondary outcomes (2)
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
Measured: Three months
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Sep 2022
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It consists of two groups, application and control, and three follow-ups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar YEL, Ege University
- Investigators
- Pinar YEL, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068725
- Sponsor's protocol ID
- EU-NF-PY-01
- Status last verified
- Sep 2023
- First submitted
- 29 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06068725
- Acronym / sponsor ID
- EU-NF-PY-01
- Conditions
- Heart Failure
- Keywords
- Quality of Life, Geriatrics, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It consists of two groups, application and control, and three follow-ups.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Training videosTwo 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Under 65 years of age
- Known serious vision and hearing problems
- With cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training videosAfter 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). | Behavioural | Experimental: application group |
Primary outcome
Heart Failure Symptom Status Scale
Time frame: Three months
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.
2 secondary outcomes
Minnesota Living with Heart Failure Questionnaire
Time frame: Three months
Michel Uncertainty in Illness Scale - Society Form
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinar YEL principal investigator
Ege University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training videos in people with Heart Failure, run by Ege University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Symptom Status Scale (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.