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Aging WellPhase 2/3PWGNCT05024903

A Novel E-health Platform

A Phase 2/3 study testing Serious illness medical planning plus the novel e-health platform (PWG 2.0) in people with Aging Well and Decision Making, run by Daren K. Heyland at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Aging Well, Decision Making, Illness, Critical
What is being tested?
Serious illness medical planning plus the novel e-health platform (PWG 2.0)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
1 Oct 2021to 22 Sep 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 25-70 years old

Who cannot join

  • don't speak or read English
  • no home internet access
  • a baseline PWB score of 4.5 or greater

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • City of Lethbridge

    Lethbridge, Alberta, T1K 5T2

Other trials in Canada

About this study

Official title: A Randomized Trial of a Novel E-health Platform (Plan Well GuideTM)

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.

Being tested
Serious illness medical planning plus the novel e-health platform (PWG 2.0), Standard of care
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • Standard of careOther

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

Study groups in NCT05024903
Study groupRoleWhat they receive
Control Group: (PWG 1.0)Active comparatorThose 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
Receives: Other: Standard of care
Intervention group: PWG 2.0Active comparatorSerious illness medical planning plus the novel e-health platform designed to help people more broadly think and plan ahead
Receives: Other: Serious illness medical planning plus the novel e-health platform (PWG 2.0)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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")

    Measured: 6 months

  2. Item scores for Preparedness for the Future Question score

    Measured for the Phase II trial

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2021
  2. Study start1 Oct 2021
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2022

Why it stopped: Unable to enroll enough patients in the time allotted. Study deemed infeasible.Dece

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05024903
Sponsor's protocol ID
PWG
Acronym
PWG
Status last verified
May 2023
First submitted
23 Aug 2021
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34193434

  • 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.

    PubMed 32345707

  • 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.

    PubMed 31542737

  • 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.

    PubMed 33858414

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Serious illness medical planning plus the novel e-health platform (PWG 2.0) in people with Aging Well and Decision Making, run by Daren K. Heyland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unable to enroll enough patients in the time allotted. Study deemed infeasible.Dece). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Preparedness for the Future Question score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05024903, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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