A Novel E-health Platform

NCT ID: NCT05024903

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-09-22

Brief Summary

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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

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Conditions

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Aging Well Decision Making Illness, Critical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Participants are not planning for their future (PWG 2.0) or using the e-health platform

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

Group Type ACTIVE_COMPARATOR

Serious illness medical planning plus the novel e-health platform (PWG 2.0)

Intervention Type OTHER

PWG 2.0 consists of the following components:

1. A diagnostic questionnaire, "Preparedness for the Future Questionnaire" and bench-marked report that helps users assess their strengths, weaknesses and opportunities for improvement.
2. A comprehensive e-workbook that helps users understand the science behind personal behavior change.
3. 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).
4. 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.
5. Monthly newsletter with current topics and issues related to the 30 topics and behavior change in general.
6. A virtual consultation with Dr. Heyland, creator of PWG and principal investigator.

Interventions

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Serious illness medical planning plus the novel e-health platform (PWG 2.0)

PWG 2.0 consists of the following components:

1. A diagnostic questionnaire, "Preparedness for the Future Questionnaire" and bench-marked report that helps users assess their strengths, weaknesses and opportunities for improvement.
2. A comprehensive e-workbook that helps users understand the science behind personal behavior change.
3. 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).
4. 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.
5. Monthly newsletter with current topics and issues related to the 30 topics and behavior change in general.
6. A virtual consultation with Dr. Heyland, creator of PWG and principal investigator.

Intervention Type OTHER

Standard of care

Participants are not planning for their future (PWG 2.0) or using the e-health platform

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daren K. Heyland

OTHER

Sponsor Role lead

Responsible Party

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Daren K. Heyland

Director of Clinical Evaluation Research Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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City of Lethbridge

Lethbridge, Alberta, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 34193434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32345707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31542737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33858414 (View on PubMed)

Other Identifiers

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PWG

Identifier Type: -

Identifier Source: org_study_id

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