Heart FailureVID-HFNCT05908617
Impact of Video Discharge Instructions on Heart Failure Patient's Knowledge
A study testing Video Discharge in people with Heart Failure, run by Yasmeen Golzar at 1 site in United States.
Trial summary
With improve care of patients with heart failure, many patients are living longer. Care for these patients is now not only focused on mortality but also on the quality of life. Patient knowledge about heart failure and their overall compliance with the necessary lifestyle changes will lead to an improved quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Video Discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 7 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospital admission with a diagnosis of Heart Failure (HF)- Heart failure with reduced ejection fraction or heart failure with preserved Ejection fraction
- planned discharge from hospital to home setting
- able to read and write English
- Acceptable to answer Questionnaire and to receive a call at the end of the study
Who cannot join
- Planned discharge to long term acute care
- Patients with unstable housing
- imprisoned patients
- patients who are pregnant
- illiteracy (defined as inability to write or read) and non-native speakers of English
- impaired cognition
Show all 9Show fewer
- impaired vision
- Patients with End Stage Renal Disease(ESRD)
- Cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure Patient Education Using Video and Paper Discharge Instructions
With improve care of patients with heart failure, many patients are living longer. Care for these patients is now not only focused on mortality but also on the quality of life. Patient knowledge about heart failure and their overall compliance with the necessary lifestyle changes will lead to an improved quality of life. Discovering alternative ways to improve patient knowledge is key to long term survival. This studies objective is to assess the overall impact of video discharge instructions as compared to paper discharge instructions on Heart Failure Knowledge among an under-served patient population.
Read the detailed description
In this study, we will randomized patients admitted to the hospital with heart failure exacerbation to receive either paper or video discharge instructions within a day prior to discharge. The video and paper instructions will have the same content. The patients will take a pre-test and post-test and the change in scores among the patients who received the video and paper discharge instructions will be compared. Other points of interest include participant satisfactions with discharge instruction, followup at post hospital appointment and 30-day readmission.
Data to be collected includes:
- Medial history of the patient
- Educational background
- Social Status
- Patients Health Measurement: Self Efficacy for managing medications and Treatment Management, Informational Support
- Conditions
- Heart Failure
- Being tested
- Video Discharge
- Keywords
- Patient knowledge, Heart Failure, Self Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video DischargeOther
Patient will watch a video discharge instructions in addition to the standard paper instructions. They will also take the pre and post test as the control group
| Study group | Role | What they receive |
|---|---|---|
| Paper Discharge Instruction | No intervention | Patient will be given paper discharge instructions |
| Video Discharge Instructions | Experimental | Patient will be given Video discharge instructions Receives: Other: Video Discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Failure Knowledge Score
Participants knowledge about heart failure will be assessed using the validated Atlanta Heart Failure Knowledge Test(AHFKT- V3). This is a test which includes 30 questions with a minimum score of 0 and a maximum score of 30. Each Participant will take the test and will subsequently be given either paper discharge instructions or both video and paper discharge instructions. After reading and/or watching the discharge instructions, each participant will take the same test once again. The difference in the pre and post intervention scores will be calculated and the investigators will assess if there is a significant difference in the mean change in score the control(Paper) vs. Intervention groups(Video).
Measured: 1hr
Secondary outcomes (3)
Participant Satisfaction with discharge Instructions
Participant overall satisfaction with their discharge instructions will be assess using a 5 point likert scale which ranges from not at all helpful to extremely helpful
Measured: 1 day
Post hospital followup rates
Upon discharge from the hospital, Each participant is given a post hospital appointment within 14 days of the discharge date. We will assess the percentage of participates in both groups who come to post hospital appointments.
Measured: 30 days
Heart Failure Readmission rates
Investigators will assess the percentage of participants in both groups who will be readmitted to the hospital within 30days after being discharged from the index visit.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 May 2018
- Primary completion7 Jul 2018
- Study completion7 Aug 2018
Why it stopped: Per PI this QI/QA resident project was not initiated. Record should be deleted.
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.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmeen Golzar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yasmeen Golzar, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908617
- Sponsor's protocol ID
- 17-538-Stroger
- Acronym
- VID-HF
- Status last verified
- Jun 2023
- First submitted
- 12 Jan 2018
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Patient Education Using Video and Paper Discharge Instructions
- ClinicalTrials.gov ID
- NCT05908617
- Acronym / sponsor ID
- VID-HF / 17-538-Stroger
- Conditions
- Heart Failure
- Keywords
- Patient knowledge, Heart Failure, Self Care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per PI this QI/QA resident project was not initiated. Record should be deleted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yasmeen GolzarOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 18 Jun 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.
With improve care of patients with heart failure, many patients are living longer. Care for these patients is now not only focused on mortality but also on the quality of life. Patient knowledge about heart failure and their overall compliance with the necessary lifestyle changes will lead to an improved quality of life. Discovering alternative ways to improve patient knowledge is key to long term survival. This studies objective is to assess the overall impact of video discharge instructions as compared to paper discharge instructions on Heart Failure Knowledge among an under-served patient population.
Detailed description
In this study, we will randomized patients admitted to the hospital with heart failure exacerbation to receive either paper or video discharge instructions within a day prior to discharge. The video and paper instructions will have the same content. The patients will take a pre-test and post-test and the change in scores among the patients who received the video and paper discharge instructions will be compared. Other points of interest include participant satisfactions with discharge instruction, followup at post hospital appointment and 30-day readmission.
Data to be collected includes:
- Medial history of the patient
- Educational background
- Social Status
- Patients Health Measurement: Self Efficacy for managing medications and Treatment Management, Informational Support
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper Discharge Instruction | No intervention | –Patient will be given paper discharge instructions |
| Video Discharge Instructions | Experimental | Other: Video DischargePatient will be given Video discharge instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hospital admission with a diagnosis of Heart Failure (HF)- Heart failure with reduced ejection fraction or heart failure with preserved Ejection fraction
- planned discharge from hospital to home setting
- able to read and write English
- Acceptable to answer Questionnaire and to receive a call at the end of the study
Key exclusion criteria (9 listed)
- Planned discharge to long term acute care
- Patients with unstable housing
- imprisoned patients
- patients who are pregnant
- illiteracy (defined as inability to write or read) and non-native speakers of English
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 |
|---|---|---|
| Video DischargePatient will watch a video discharge instructions in addition to the standard paper instructions. They will also take the pre and post test as the control group | Other | Video Discharge Instructions |
Primary outcome
Change in Heart Failure Knowledge Score
Time frame: 1hr
Participants knowledge about heart failure will be assessed using the validated Atlanta Heart Failure Knowledge Test(AHFKT- V3). This is a test which includes 30 questions with a minimum score of 0 and a maximum score of 30. Each Participant will take the test and will subsequently be given either paper discharge instructions or both video and paper discharge instructions. After reading and/or watching the discharge instructions, each participant will take the same test once again. The difference in the pre and post intervention scores will be calculated and the investigators will assess if there is a significant difference in the mean change in score the control(Paper) vs. Intervention groups(Video).
3 secondary outcomes
Participant Satisfaction with discharge Instructions
Time frame: 1 day
Post hospital followup rates
Time frame: 30 days
Heart Failure Readmission rates
Time frame: 30days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Discharge in people with Heart Failure, run by Yasmeen Golzar at 1 site in United States.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Heart Failure Knowledge Score (time frame: 1hr). 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 18 Jun 2023.