Congestive Heart FailureNCT01653938
A Trial of a CPR Video in Heart Failure Patients
A study testing video decision aid in people with Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- video decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A diagnosis of advanced heart failure:
- New York Heart Association Class III or IV (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest). AND
- Two or more hospitalizations for heart failure in the last year. AND
- Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
- Ability to provide informed consent.
- Ability to communicate in English.
- Age 65 or older.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Angelo Volandes, 617-643-4266, avolandes@partners.org
Angelo Volandes
About this study
Official title: A Randomized Controlled Trial of a CPR Video in Heart Failure Patients
This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).
Read the detailed description
Aim 1: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 1: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.
Aim 2: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.
Hypothesis 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video.
Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.
- Conditions
- Congestive Heart Failure
- Being tested
- video decision aid
- Keywords
- CHF
- 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 decision aidBehavioural
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| Video Arm | Experimental | Use of video decision aid in the experimental arm. Receives: Behavioral: video decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
preferences
preferences for cpr and intubation
Measured: 5 minutes after survey
Secondary outcomes (3)
knowledge
knowledge of cpr and intubation
Measured: 5 minutes after survey
decisional conflict
decisional conflict
Measured: 5 minutes after survey
advance care planning documentation
advance care planning in medical record
Measured: by the end of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo E. Volandes, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653938
- Sponsor's protocol ID
- 2009-P-002083
- Status last verified
- Nov 2020
- First submitted
- 24 Jul 2012
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a CPR Video in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01653938
- Acronym / sponsor ID
- 2009-P-002083
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- 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.
This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).
Detailed description
Aim 1: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 1: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.
Aim 2: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.
Hypothesis 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video.
Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.
Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| Video Arm | Experimental | Behavioral: video decision aidUse of video decision aid in the experimental arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- A diagnosis of advanced heart failure:
- Ability to provide informed consent.
- Ability to communicate in English.
- Age 65 or older.
Key exclusion criteria (0 listed)
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 decision aid | Behavioural | Video Arm |
Primary outcome
preferences
Time frame: 5 minutes after survey
preferences for cpr and intubation
3 secondary outcomes
knowledge
Time frame: 5 minutes after survey
decisional conflict
Time frame: 5 minutes after survey
advance care planning documentation
Time frame: by the end of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
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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.
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 decision aid in people with Congestive Heart Failure, run by Massachusetts General Hospital 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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preferences (time frame: 5 minutes after survey). 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 Nov 2020.