Mild Cognitive ImpairmentENACT-aMCINCT03711396

ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment

A study testing Advance Care Planning Group Visits in people with Mild Cognitive Impairment, run by University of Colorado, Denver at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: Advance Care Planning Group Visits
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: 1 Feb 2019to 15 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

diagnosis of amnestic mild cognitive impairment
ability to provide consent
have a study partner who has regular interaction with the patient

Who cannot join

known prior diagnosis of deafness/hearing loss that would limit group discussion participation
inability to travel to study location
not having access to a phone for follow up
not having an individual who is able to serve as a study partner to the patient
normal cognitive screen based on SPMSQ

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UCHealth
Aurora, Colorado, 80045
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)

The Advance Care Planning Group Visit intervention is a new intervention that uses the strengths of group visits to promote advance care planning conversations and documentation. However, the Advance Care Planning Group Visit intervention was initially designed for individuals without cognitive impairment. This study will specifically investigate ways to adapt the Advance Care Planning Group Visit intervention for individuals with amnestic Mild Cognitive Impairment and their family care partners.

Read the detailed description

Advance care planning is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The goal of advance care planning is to help ensure that people receive medical care that is consistent with their values, goals and preferences during serious and chronic illness.

This is a pilot test of the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.

This aim will use rapid-cycle prototyping (n-of-1 interventions) to conduct the ENgaging in Advance Care planning Talks (ENACT) Memory Group Visits, adapting them for individuals with amnestic Mild Cognitive Impairment. Each n-of-1 prototype will include up to 10 patient-study partner dyads meeting in up to two 2-hour group medical visit sessions, one month apart. Four cohorts will be conducted so that approximately 40 participants are involved in the n-of-1 prototypes of the ENACT Memory Group Visit intervention. The intervention will be conducted based on an intervention manual that will be refined and adapted with input from patients, study partners, and the research team of multidisciplinary clinicians. Participants will receive the Colorado Medical Durable Power of Attorney form and other appropriate advance care planning resources for individuals with aMCI.

Conditions: Mild Cognitive Impairment
Being tested: Advance Care Planning Group Visits
Keywords: Advance Care Planning
Medical subject headings: Cognitive Dysfunction

What participants receive

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

Advance Care Planning Group VisitsBehavioural
Pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.

Study groups in NCT03711396
Study group	Role	What they receive
Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment	Experimental	Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice. Receives: Behavioral: Advance Care Planning Group Visits
Advance Care Planning Group Visits - Care Partners	Experimental	Care partners of persons with amnestic Mild Cognitive Impairment will attend group visits, with the person with Mild Cognitive Impairment, to discuss advance care planning. Group visits will last up to two hours and be help up to twice. Receives: Behavioral: Advance Care Planning Group Visits

What is being measured

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

Change in Readiness to Engage in ACP (ACP Engagement Scale)
The Advance Care Planning (ACP) Engagement Scale will be used to assess readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing). Items are rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate a higher level of engagement with the advance care planning behavior and a better outcome.
Measured: 0, 3 months

Secondary outcomes (1)

Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Care partner report of the Advance Care Planning (ACP) Engagement Scale will be used to assess care partner perspectives on the person with amnestic mild cognitive impairment's readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing). Items are rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate a higher level of engagement with the advance care planning behavior and a better outcome.
Measured: 0, 3 months

Timeline

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

1 Feb 201915 Jan 2021

First posted18 Oct 2018
Study start1 Feb 2019
Primary completion31 Oct 2020
Study completion15 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Model description: We will conduct four n-of-1 group visit interventions for advance care planning.
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03711396
Sponsor's protocol ID: 18-1459
Acronym: ENACT-aMCI
Status last verified: Oct 2021
First submitted: 11 Oct 2018
Last updated: 22 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lum HD, Jones J, Matlock DD, Glasgow RE, Lobo I, Levy CR, Schwartz RS, Sudore RL, Kutner JS. Advance Care Planning Meets Group Medical Visits: The Feasibility of Promoting Conversations. Ann Fam Med. 2016 Mar;14(2):125-32. doi: 10.1370/afm.1906.
PubMed 26951587
Lum HD, Sudore RL, Matlock DD, Juarez-Colunga E, Jones J, Nowels M, Schwartz RS, Kutner JS, Levy CR. A Group Visit Initiative Improves Advance Care Planning Documentation among Older Adults in Primary Care. J Am Board Fam Med. 2017 Jul-Aug;30(4):480-490. doi: 10.3122/jabfm.2017.04.170036.
PubMed 28720629
Lum HD, Dukes J, Daddato AE, Juarez-Colunga E, Shanbhag P, Kutner JS, Levy CR, Sudore RL. Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care. J Am Geriatr Soc. 2020 Oct;68(10):2382-2389. doi: 10.1111/jgs.16694. Epub 2020 Jul 29.
PubMed 32726475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Enrolling by invitation
Mild Cognitive Impairment and Neuromodulation
Mild Cognitive Impairment (MCI)

All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT) for Individuals With Amnestic Mild Cognitive Impairment (aMCI)
ClinicalTrials.gov ID: NCT03711396
Acronym / sponsor ID: ENACT-aMCI / 18-1459
Conditions: Mild Cognitive Impairment
Keywords: Advance Care Planning
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 1 Feb 2019 (actual)
Primary completion: 31 Oct 2020 (actual)
Study completion: 15 Jan 2021 (actual)
First posted: 18 Oct 2018 (actual)
Results: Posted 22 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: We will conduct four n-of-1 group visit interventions for advance care planning.

Arm	Type	Receives
Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment	Experimental	Behavioral: Advance Care Planning Group VisitsParticipants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
Advance Care Planning Group Visits - Care Partners	Experimental	Behavioral: Advance Care Planning Group VisitsCare partners of persons with amnestic Mild Cognitive Impairment will attend group visits, with the person with Mild Cognitive Impairment, to discuss advance care planning. Group visits will last up to two hours and be help up to twice.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

diagnosis of amnestic mild cognitive impairment
ability to provide consent
have a study partner who has regular interaction with the patient

Key exclusion criteria (5 listed)

known prior diagnosis of deafness/hearing loss that would limit group discussion participation
inability to travel to study location
not having access to a phone for follow up
not having an individual who is able to serve as a study partner to the patient
normal cognitive screen based on SPMSQ

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advance Care Planning Group VisitsPilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences.	Behavioural	Advance Care Planning Group Visits - Care Partners, Advance Care Planning Group Visits - amnestic Mild Cognitive Impairment

Primary outcome

Change in Readiness to Engage in ACP (ACP Engagement Scale)
Time frame: 0, 3 months
The Advance Care Planning (ACP) Engagement Scale will be used to assess readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing). Items are rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate a higher level of engagement with the advance care planning behavior and a better outcome.

1 secondary outcome

Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Time frame: 0, 3 months

Results and safety

Results posted to the registry on 22 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Advance Care Planning Group Visits - aMCI	13	13
Advance Care Planning Group Visits - Care Partners	13	13

Primary outcome: Change in Readiness to Engage in ACP (ACP Engagement Scale)

Time frame: 0, 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Advance Care Planning Group Visits - Persons With aMCI n = 13
Readiness to sign official papers naming a medical decision maker at 0 months	1.92 (1.12)
Readiness to talk to decision maker at 0 months	1.54 (0.88)
Readiness to talk to doctor at 0 months	2.77 (1.36)
Readiness to sign papers putting wishes into writing at 0 months	2.00 (1.15)
Readiness to sign official papers naming a medical decision maker at 3 months	1.77 (0.93)
Readiness to talk to decision maker at 3 months	2.38 (0.96)
Readiness to talk to doctor at 3 months	2.00 (0.91)
Readiness to sign papers putting wishes into writing at 3 months	2.08 (1.16)

Population analysed: Participants with aMCI

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Advance Care Planning Group Visits	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26951587Lum HD, Jones J, Matlock DD, Glasgow RE, Lobo I, Levy CR, Schwartz RS, Sudore RL, Kutner JS. Advance Care Planning Meets Group Medical Visits: The Feasibility of Promoting Conversations. Ann Fam Med. 2016 Mar;14(2):125-32. doi: 10.1370/afm.1906.
Background: PubMed 28720629Lum HD, Sudore RL, Matlock DD, Juarez-Colunga E, Jones J, Nowels M, Schwartz RS, Kutner JS, Levy CR. A Group Visit Initiative Improves Advance Care Planning Documentation among Older Adults in Primary Care. J Am Board Fam Med. 2017 Jul-Aug;30(4):480-490. doi: 10.3122/jabfm.2017.04.170036.
Background: PubMed 32726475Lum HD, Dukes J, Daddato AE, Juarez-Colunga E, Shanbhag P, Kutner JS, Levy CR, Sudore RL. Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care. J Am Geriatr Soc. 2020 Oct;68(10):2382-2389. doi: 10.1111/jgs.16694. Epub 2020 Jul 29.
Individual participant dataSharing planned: No

Related trials for Mild Cognitive Impairment

Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Enrolling by invitation
Mild Cognitive Impairment and Neuromodulation
Mild Cognitive Impairment (MCI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Advance Care Planning Group Visits in people with Mild Cognitive Impairment, run by University of Colorado, Denver at 2 sites in United States.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Readiness to Engage in ACP (ACP Engagement Scale) (time frame: 0, 3 months). 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 NCT03711396, which also lists 3 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 22 Nov 2021.