A Novel E-health Platform

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05024903
Study type	Interventional
Source	Clinical Evaluation Research Unit at Kingston General Hospital
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	October 1, 2021
Completion date	September 22, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Novel E-health Platform — PWG

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms