A Novel E-health Platform (PWG)
Primary Purpose
Aging Well, Decision Making, Illness, Critical
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Serious illness medical planning plus the novel e-health platform (PWG 2.0)
Standard of care
Sponsored by
About this trial
This is an interventional supportive care trial for Aging Well
Eligibility Criteria
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
Sites / Locations
- City of Lethbridge
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control Group: (PWG 1.0)
Intervention group: PWG 2.0
Arm Description
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
Serious illness medical planning plus the novel e-health platform designed to help people more broadly think and plan ahead
Outcomes
Primary Outcome Measures
Overall Preparedness for the Future Question score
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")
Item scores for Preparedness for the Future Question score
Measured for the Phase II trial
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024903
Brief Title
A Novel E-health Platform
Acronym
PWG
Official Title
A Randomized Trial of a Novel E-health Platform (Plan Well GuideTM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Unable to enroll enough patients in the time allotted. Study deemed infeasible.Dece
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daren K. Heyland
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
The purpose of the current trial is to evaluate a novel e-health platform. Overall Hypothesis: Participants who receive Plan Well Guide (PWG) 2.0 will make more progress in their 'preparations' as measured by "Preparedness for the Future Questionnaire (PREP FQ)" at 6 months and, consequently, experience greater improvements in their psychological well-being (PWB), health status, and life satisfaction at 12 months compared to participants receiving PWG 1.0 (Advance Serious Illness module only). Study Design: The investigators propose to conduct a multi-site randomized trial to evaluate a novel e-health platform. Overall Hypothesis: Participants who receive Plan Well Guide (PWG) 2.0 will make more progress in their 'preparations' as measured by "Preparedness for the Future Questionnaire (PREP FQ)" at 6 months and, consequently, experience greater improvements in their psychological well-being (PWB), health status, and life satisfaction at 12 months compared to participants receiving PWG 1.0 (Advance Serious Illness module only).Study Design: We propose to conduct a multi-site randomized trial. Setting: Several sites in Lethbridge Alberta. a sample of primary care clinics as well as recruit online participants. Study Population: The investigators plan to include interested participants that are aged between 25 to 70 years of age. We will exclude participants that don't speak English or do not have internet access/email addresses, and already have a high PWB score. Study Intervention: Eligible participants will then be randomly allocated to 2 groups: PWG 1.0 or PWG 2.0.Outcomes: The primary outcome for this trial will be an overall score of PWB questionnaire; key secondary outcomes include PWB domain scores, SF-12,single-item rating of life satisfaction, all measured at 6 and 12 months. Additional outcomes include 'days off work' and health care utilization. Significance: This study will be the first large multi-centre trial examining the effects of a novel e-health platform aimed at improving people's psychological well-being and health status as well as their preparedness for serious illness decision-making during this time of a global pandemic. Results of this trial will likely affect the state of preparedness of individuals, and if wide disseminated, may have a dramatic effect on the health and well-being of a broad segment of the population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging Well, Decision Making, Illness, Critical
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group: (PWG 1.0)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intervention group: PWG 2.0
Arm Type
Active Comparator
Arm Description
Serious illness medical planning plus the novel e-health platform designed to help people more broadly think and plan ahead
Intervention Type
Other
Intervention Name(s)
Serious illness medical planning plus the novel e-health platform (PWG 2.0)
Intervention Description
PWG 2.0 consists of the following components:
A diagnostic questionnaire, "Preparedness for the Future Questionnaire" and bench-marked report that helps users assess their strengths, weaknesses and opportunities for improvement.
A comprehensive e-workbook that helps users understand the science behind personal behavior change.
Links to webpages with additional e-workbooks and curated content aimed to help users progress on the 30 different attitudes, behaviors, and activities that portend for a better future (topics listed in Appendix A).
E-messages delivered via emails (via text an option for those that prefer) with tailored content designed to provide multiple nudges to guide the user to progress through our content.
Monthly newsletter with current topics and issues related to the 30 topics and behavior change in general.
A virtual consultation with Dr. Heyland, creator of PWG and principal investigator.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Participants are not planning for their future (PWG 2.0) or using the e-health platform
Primary Outcome Measure Information:
Title
Overall Preparedness for the Future Question score
Description
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")
Time Frame
6 months
Title
Item scores for Preparedness for the Future Question score
Description
Measured for the Phase II trial
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Overall score of Psychological Well Being Scale
Description
Scale is 42 to 294 and the higher scores indicate greater wellbeing
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
City of Lethbridge
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1K 5T2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34193434
Citation
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.
Results Reference
background
PubMed Identifier
32345707
Citation
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.
Results Reference
background
PubMed Identifier
31542737
Citation
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.
Results Reference
background
PubMed Identifier
33858414
Citation
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.
Results Reference
background
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A Novel E-health Platform
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