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Effectiveness of the HF-ACP Website Study

Randomized Controlled Trial of an Interactive Website for Heart Failure Advance Care Planning

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03539510
Enrollment
20
Registered
2018-05-29
Start date
2018-05-31
Completion date
2019-04-30
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advance Care Planning, Heart Failure

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.

Interventions

BEHAVIORALHF-ACP Website

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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Advance care planning completion rates6 monthsproportion of participants who complete the advance care planning process

Secondary

MeasureTime frameDescription
The 5-level European Quality of Life scale6 monthsThe 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)6 monthsThe 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.
advance care planning knowledge6 months% improvement in knowledge of advance care planning
The Patient Health Questionnaire (PHQ-9)6 monthsThe 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 Scale6 monthsThe PSS is a 10 item self-administered scale to measure perceived stress. The scores range form 0-40 with higher scores representing greater stress.
The Readiness to Change Scale (RCS)6 monthsThe 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

Contacts

Primary ContactJane Maciver, RN PhD
jane.maciver@uhn.ca4163404622
Backup ContactRobert Nolan, PhD
rnolan@uhnres.utoronto.ca4163404800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026