Our Care Wishes - Dementia

June 21, 2023 updated by: University of Pennsylvania

Adaptation of the OurCareWishes.Org ACP Platform for Persons With Dementia in NHs and Their Caregivers

This Our Care Wishes- Dementia pilot study is adapting an existing successful online advance care planning platform to the specific needs of persons living with dementia and shared decision-makers (SDMs) and testing the usability and acceptability among nursing home residents and SDMs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4217
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Eligible PLWD will be receiving short-or long-term care at a participating NH, have documented moderate to severe cognitive impairment as measured by the Cognitive Function Scale included in the Minimum Data Set 3.0, 65 and have an identified SDM.

Exclusion Criteria:

  • Participants are not eligible discharged from participating NHs, or do not have access to a telephone or video chat.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Participants who are allocated to the control arm will complete baseline measures and then receive usual advanced care planning care and discussions with the nursing facility staff. Control arm participants will not review the Our Memory Care Wishes website. Participants will complete follow up measures one week after the baseline interview.
Experimental: Intervention
Participants allocated to the intervention group will complete baseline measures. Then, the participant will review the Our Memory Care Wishes website and enter advanced care planning decisions and preferences into the website. Participants will complete follow up measures one week after the baseline interview. Participants receiving the intervention will complete additional follow up measures which include surveys measuring the ease of use of the website.
Other: Our Memory Care Wishes
Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document healthcare and daily life preferences with the help of shared decision-makers. Penn researchers meet via Zoom with PLWD and their SDMS and nursing home staff to facilitate website completion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adapted Decision Making Confidence Scale
Time Frame: Baseline
Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident).
Baseline
Post Adapted Decision Making Confidence Scale
Time Frame: 1 week
Items from the Surrogate Decision-Making Confidence Scale and 9-item ACP Engagement Survey were used and adapted to capture the confidence in advanced care planning decision-making from both persons living with dementia and their shared decision-maker' points of view. The scale utilizes a Likert scale with values ranging from 1 (not confident at all) to 5 (very confident). This is the second time point the measure was collected.
1 week
Website Ease of Use
Time Frame: 1 week
This scale measures the ease of use of the website. This scale uses a Likert scale from 0 (very hard) to 10 (very easy). These data were collected from PLWDs and SDMs in the intervention group.
1 week
Rate of ACP Website Completion - Time
Time Frame: 1 week
This tool measured total time spent by participants on the advance care planning website. Total time in minutes spent on the website were collected. Because SDMs navigated the website with the PLWD alongside them, this measure was only used to SDMs in the intervention group.
1 week
Rate of ACP Website Completion - Questions Completed
Time Frame: 1 week
This tool measured what percentage of the website was completed by participants. Because SDMs navigated the website with the PLWD alongside them, this measure was only associated with SDMs in the intervention group.
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
COVID-19 Impact Questionnaire
Time Frame: 1 week
This scale measures how participants' advance care planning decisions were impacted by the COVID-19 pandemic. Participants can choose whether or not the COVID-19 pandemic affected their healthcare preferences, specifically if participants prefer to receive care via a ventilator and if participants prefer to receive treatment in nursing facility over visiting the hospital.
1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
COVID-19 Impact Questionnaire
Time Frame: 1 week

Participants were asked if their healthcare preferences changed due to the COVID-19 pandemic. Items included:

  1. Since COVID, planning for the future is: (1) less important (2) more important, or (3) the same
  2. Since COVID, the sense of urgency to name a supportive decision maker has: (1) increased (2) decreased, or (3) remained the same.
  3. Since COVID, my preferences for decisions about breathing machines (ventilators) have: (1) changed or (2) remained the same.
  4. Since COVID, my preferences for going to the hospital for care versus receiving treatment in place have:(1) changed, or (2) remained the same.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 834878
  • P30AG064105-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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