Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 10:22 AM
Study NCT ID:
NCT05024903
Status:
TERMINATED
Last Update Posted:
2023-05-10
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel E-health Platform
Sponsor:
Daren K. Heyland
Organization:
Study Overview
Official Title:
A Randomized Trial of a Novel E-health Platform (Plan Well GuideTM)
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to enroll enough patients in the time allotted. Study deemed infeasible.Dece
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PWG
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: