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Effectiveness of the HF-ACP Website Study

Primary Purpose

Heart Failure, Advance Care Planning

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HF-ACP Website
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • ineligible for participation in the trial if they do not meet the inclusion criteria described above.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    HF-ACP Website

    Usual Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Advance care planning completion rates
    proportion of participants who complete the advance care planning process

    Secondary Outcome Measures

    advance care planning knowledge
    % improvement in knowledge of advance care planning
    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.
    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.
    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
    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
    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.

    Full Information

    First Posted
    July 4, 2017
    Last Updated
    May 28, 2018
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03539510
    Brief Title
    Effectiveness of the HF-ACP Website Study
    Official Title
    Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2018 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Advance Care Planning

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HF-ACP Website
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    HF-ACP Website
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Advance care planning completion rates
    Description
    proportion of participants who complete the advance care planning process
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    advance care planning knowledge
    Description
    % improvement in knowledge of advance care planning
    Time Frame
    6 months
    Title
    The 5-level European Quality of Life scale
    Description
    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.
    Time Frame
    6 months
    Title
    Generalized Anxiety Disorder Scale (GAD-7)
    Description
    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.
    Time Frame
    6 months
    Title
    The Readiness to Change Scale (RCS)
    Description
    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
    Time Frame
    6 months
    Title
    The Patient Health Questionnaire (PHQ-9)
    Description
    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
    Time Frame
    6 months
    Title
    The Perceived Stress Scale
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: ineligible for participation in the trial if they do not meet the inclusion criteria described above.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jane Maciver, RN PhD
    Phone
    4163404622
    Email
    jane.maciver@uhn.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Nolan, PhD
    Phone
    4163404800
    Ext
    6400
    Email
    rnolan@uhnres.utoronto.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jane Maciver, RN PhD
    Organizational Affiliation
    UHN Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effectiveness of the HF-ACP Website Study

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