- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05024903
A Novel E-health Platform (PWG)
A Randomized Trial of a Novel E-health Platform (Plan Well GuideTM)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Alberta
-
Lethbridge, Alberta, Canada, T1K 5T2
- City of Lethbridge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 25-70 years old
Exclusion Criteria:
- don't speak or read English
- no home internet access
- a baseline PWB score of 4.5 or greater
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group: (PWG 1.0)
Those randomized to PWG 1.0 would have already completed their serious illness medical planning.
Further involvement in the trial will be solely for the purposes of the outcome data collection
|
Participants are not planning for their future (PWG 2.0) or using the e-health platform
|
Active Comparator: Intervention group: PWG 2.0
Serious illness medical planning plus the novel e-health platform designed to help people more broadly think and plan ahead
|
PWG 2.0 consists of the following components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Preparedness for the Future Question score
Time Frame: 6 months
|
All scores were re-scaled to range between 0 (worst -lowest possible total points given the applica- ble answered questions) and 100 (best -highest possible total points given applicable answered questions). Measured for the Phase II trial: the questionnaire contains 34 items in 8 distinct domains ("Medico-legal", "Social", "Psychological Well-being", "Planning", "Enrichment", "Positive Health Behaviors", "Negative Health Behaviors", and "Late-life Planning") |
6 months
|
Item scores for Preparedness for the Future Question score
Time Frame: 6 months
|
Measured for the Phase II trial
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall score of Psychological Well Being Scale
Time Frame: 12 months
|
Scale is 42 to 294 and the higher scores indicate greater wellbeing
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Howard M, Elston D, Borhan S, Hafid A, Arora N, Forbes R, Bernard C, Heyland DK. Randomised trial of a serious illness decision aid (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning. BMJ Support Palliat Care. 2022 Mar;12(1):99-106. doi: 10.1136/bmjspcare-2021-003040. Epub 2021 Jun 30.
- Heyland DK, Heyland R, Bailey A, Howard M. A novel decision aid to help plan for serious illness: a multisite randomized trial. CMAJ Open. 2020 Apr 28;8(2):E289-E296. doi: 10.9778/cmajo.20190179. Print 2020 Apr-Jun.
- Howard M, Slaven M, Bernard C, Borhan S, Elston D, Arora N, Tan A, Heyland DK. Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial. BMJ Open. 2019 Sep 20;9(9):e027897. doi: 10.1136/bmjopen-2018-027897.
- Heyland DK, Pope JP, Jiang X, Day AG. Determining the psychometric properties of a novel questionnaire to measure "preparedness for the future" (Prep FQ). Health Qual Life Outcomes. 2021 Apr 15;19(1):122. doi: 10.1186/s12955-021-01759-z.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PWG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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