Heart FailureNCT03539510
Effectiveness of the HF-ACP Website Study
A study testing HF-ACP Website in people with Heart Failure and Advance Care Planning, run by University Health Network, Toronto.
Trial summary
This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Advance Care Planning
- What is being tested?
- HF-ACP Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Apr 2019
- 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
- over the age of 18,
- a regular patient in our clinic,
- able to read and write English,
- familiar with the use and have access to a personal computer, email and the internet.
Who cannot join
- ineligible for participation in the trial if they do not meet the inclusion criteria described above.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning
This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.
Read the detailed description
Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care. Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates. Content intended for use by the general public may be too vague for those living with a chronic illness. Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP. The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.
- Conditions
- Heart Failure, Advance Care Planning
- Being tested
- HF-ACP Website
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-ACP WebsiteBehavioural
Each module is broken down into weekly topics and each module takes 3-6 weeks to complete. Participants can access and review the material as often as needed as well as revisiting the information from modules they have completed.
| Study group | Role | What they receive |
|---|---|---|
| HF-ACP Website | Experimental | The HF-ACP website leads participants through 4 e-learning modules. Each module contains 3 core elements: (1) educational content which provides information and support to help patients complete the module (2) interactive tools for documenting their thoughts and progress and (3) motivational video clips that encourage behavior change by validating participants ambivalence, suggesting strategies to help participants complete the task and to encourage and reassure participants that they can do this. Receives: Behavioral: HF-ACP Website |
| Usual Care | No intervention | The standard of care for advance care planning at our institution is the "Speak Up" booklet and the Power of Attorney workbook from the Attorney General's Office - Ontario. Patients randomized to the Control arm will be asked to register on a separate research portal where participants will have electronic access to both of the booklets and a link to the Speak Up online Interactive workbook. There is no specific information on HF or HF treatments. Participants in the control arm will be asked to complete the ACP using the interactive workbook. Participants in the control arm will not receive any additional communication from the research team about their progress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advance care planning completion rates
proportion of participants who complete the advance care planning process
Measured: 6 months
Secondary outcomes (6)
advance care planning knowledge
% improvement in knowledge of advance care planning
Measured: 6 months
The 5-level European Quality of Life scale
The EQ-5D-5L is a generic quality of life measure that consists of a 5-item health state assessment and a visual analog scale. The dimensions represented in the 5-item assessment include: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses to the questions can be converted to a time tradeoff utility score from 0 (represents worst possible health) to 1.0 (represents perfect health). The visual analog scale ranges from 0-100 with higher scores representing better quality of life.
Measured: 6 months
Generalized Anxiety Disorder Scale (GAD-7)
The GAD-7 is a 7 item self-administered screening tool for anxiety. Scores range from 0-21 with cutoffs at 5, 10, and 15 representing mild, moderate and severe anxiety, respectively.
Measured: 6 months
The Readiness to Change Scale (RCS)
The RCS is a study-specific tool based on Prochaska's algorithm for change. It categorizes participants into one of the 5 categories of readiness. The RCS will be used to measure change for the 3 discreet behaviors: (1) identifying a SDM, (2) developing the advance care plan and (3) communicating wishes to their SDM. The RCS will be used to determine if readiness is associated with ACP completion
Measured: 6 months
The Patient Health Questionnaire (PHQ-9)
The PHQ -9 is a 9 item self-administered scale screening tool for depression. Scores range from 0-27 with cutoffs at 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe depression
Measured: 6 months
The Perceived Stress Scale
The PSS is a 10 item self-administered scale to measure perceived stress. The scores range form 0-40 with higher scores representing greater stress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study startMay 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
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 University Health Network, TorontoThe 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
- will be conducted using a single center, double-blind randomized controlled trial with 2 groups; an intervention group using the HF-ACP website and control group receiving usual care.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane MacIver, University Health Network, Toronto
- Investigators
- Jane Maciver, RN PhD, Principal investigator, UHN Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539510
- Sponsor's protocol ID
- HF-ACP website
- Status last verified
- May 2018
- First submitted
- 4 Jul 2017
- Last updated
- 30 May 2018
- 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 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning
- ClinicalTrials.gov ID
- NCT03539510
- Acronym / sponsor ID
- HF-ACP website
- Conditions
- Heart Failure, Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 29 May 2018 (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.
This study evaluates the effectiveness of an interactive website on advance care planning for patients living with heart failure (HF-ACP website). The investigators will randomize patients to either the HF-ACP website or usual care to determine if the participants who use the HF-ACP website have higher advance care planning completion rates than participants assigned to usual care.
Detailed description
Advance care planning is a process that supports adults at any age or stage of health to understand and share their personal values, life goals and preferences in order to prepare for future decisions regarding medical care. Public awareness campaigns to promote ACP have been taking place for about 10 years without significant improvements in ACP completion rates. Content intended for use by the general public may be too vague for those living with a chronic illness. Framing ACP within the context of a specific disease may provide the impetus for a person to engage in ACP. The investigators believe the HF-ACP website will improve patient understanding of the life-limiting nature of HF, the ACP process and the need to plan ahead to help ensure the care they receive matches their treatment preferences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- will be conducted using a single center, double-blind randomized controlled trial with 2 groups; an intervention group using the HF-ACP website and control group receiving usual care.
| Arm | Type | Receives |
|---|---|---|
| HF-ACP Website | Experimental | Behavioral: HF-ACP WebsiteThe HF-ACP website leads participants through 4 e-learning modules. Each module contains 3 core elements: (1) educational content which provides information and support to help patients complete the module (2) interactive tools for documenting their thoughts and progress and (3) motivational video clips that encourage behavior change by validating participants ambivalence, suggesting strategies to help participants complete the task and to encourage and reassure participants that they can do this. |
| Usual Care | No intervention | –The standard of care for advance care planning at our institution is the "Speak Up" booklet and the Power of Attorney workbook from the Attorney General's Office - Ontario. Patients randomized to the Control arm will be asked to register on a separate research portal where participants will have electronic access to both of the booklets and a link to the Speak Up online Interactive workbook. There is no specific information on HF or HF treatments. Participants in the control arm will be asked to complete the ACP using the interactive workbook. Participants in the control arm will not receive any additional communication from the research team about their progress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over the age of 18,
- a regular patient in our clinic,
- able to read and write English,
- familiar with the use and have access to a personal computer, email and the internet.
Key exclusion criteria (1 listed)
- ineligible for participation in the trial if they do not meet the inclusion criteria described above.
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 |
|---|---|---|
| HF-ACP WebsiteEach module is broken down into weekly topics and each module takes 3-6 weeks to complete. Participants can access and review the material as often as needed as well as revisiting the information from modules they have completed. | Behavioural | HF-ACP Website |
Primary outcome
Advance care planning completion rates
Time frame: 6 months
proportion of participants who complete the advance care planning process
6 secondary outcomes
advance care planning knowledge
Time frame: 6 months
The 5-level European Quality of Life scale
Time frame: 6 months
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 6 months
The Readiness to Change Scale (RCS)
Time frame: 6 months
The Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
The Perceived Stress Scale
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- 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.
Jane Maciver, RN PhD principal investigator
UHN Toronto
Questions about this trial
What is this clinical trial studying?
A study testing HF-ACP Website in people with Heart Failure and Advance Care Planning, run by University Health Network, Toronto.
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 1 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jane Maciver, RN PhD (4163404622, jane.maciver@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance care planning completion rates (time frame: 6 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 30 May 2018.