Effectiveness of the HF-ACP Website Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03539510
• Other study ID #: HF-ACP website
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2018
• Est. completion date: April 2019

Study information

• Verified date: May 2018
• Source: University Health Network, Toronto
• Contact: Jane Maciver, RN PhD
• Phone: 4163404622
• Email: jane.maciver[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 planning completion rates than participants assigned to usual care.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advance Care Planning
• Heart Failure

Intervention

Behavioral:
• HF-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advance care planning completion rates	proportion of participants who complete the advance care planning process	6 months
Secondary	advance care planning knowledge	% improvement in knowledge of advance care planning	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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.	6 months