Effectiveness of the HF-ACP Website Study

NCT03539510 | Unknown

• 1 other identifier: HF-ACP website
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Advance Care Planning

Outcome Measures

Primary Outcomes (1)

• Advance care planning completion rates

  proportion of participants who complete the advance care planning process

  6 months

Secondary Outcomes (6)

• advance care planning knowledge

  6 months

• The 5-level European Quality of Life scale

  6 months

• Generalized Anxiety Disorder Scale (GAD-7)

  6 months

• The Readiness to Change Scale (RCS)

  6 months

• The Patient Health Questionnaire (PHQ-9)

  6 months

Study Arms (2)

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.

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.

Interventions

HF-ACP Website BEHAVIORAL

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.

HF-ACP Website

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jane Maciver, RN PhD

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Maciver, RN PhD

CONTACT

4163404622; jane.maciver@uhn.ca

Robert Nolan, PhD

CONTACT

4163404800; rnolan@uhnres.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ted Rogers Nursing Professor in Cardiovascular Research

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: May 29, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share