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SHARE Protocol for Cognitive Impairment

N/A
Waitlist Available
Led By Jennifer Wolff, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient: 80 years or older, English speaking, able to provide informed consent themselves or through their legally authorized representative, identify a family member or friend who plays an active role in care coordination or accompanies them to primary care visits, not planning to move out of state within the next year, and cognitive impairment (mild-severe) on the basis of one or more incorrect answers or not being able to respond to a validated 6-item telephone screening instrument.
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 months after patient death
Awards & highlights

Study Summary

This trial is testing whether the SHARE protocol leads to better communication and advance care planning among primary care patients with cognitive impairment and their family caregivers, compared to a control group receiving minimally enhanced usual care. SHARE includes two in-person meetings and three phone calls between the patient and caregiver and a primary care clinician.

Who is the study for?
This trial is for pairs ('dyads') where one person has mild to severe cognitive impairment, is 80 or older, and the other is a family member or friend over 18 who helps with their medical care. Both must speak English and not plan to move out of state within a year. The patient should be able to consent or have someone who can on their behalf.Check my eligibility
What is being tested?
The SHARE study compares two approaches in primary care: 'SHARE', which focuses on sharing healthcare wishes, versus minimally enhanced usual care. It looks at how well these methods work for improving communication about end-of-life decisions among patients with cognitive issues and their caregivers.See study design
What are the potential side effects?
Since this trial involves communication strategies rather than medications, there are no direct physical side effects expected from participating in the SHARE protocol compared to usual care.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 80 or older, speak English, can consent to treatment, have a supportive person, plan to stay in-state, and may have some memory issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 months after patient death
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 months after patient death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Between-Group Differences in Family-Reported Quality of Communication at 6-Months
Secondary outcome measures
Between-Group Differences in Bereaved Family Symptoms of Anxiety
Between-Group Differences in Bereaved Family-Reported Decisional Conflict
Between-Group Differences in Bereaved Family-Reported Decisional Regret
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SHAREExperimental Treatment1 Intervention
SHARE components include: 1) a letter from the practice introducing the initiative, 2) access to a designated person (medical assistant, social worker, nurse, or lay person) trained to lead advance care planning discussions, 3) person-family agenda-setting to align perspectives about the role of the caregiver and stimulate discussion about goals of care, and 4) education about communication and available resources, including a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor", a blank easy to complete advance directive, and facilitated registration to the patient portal (for patient and caregiver participants) to extend electronic interactions and information access to family.
Group II: Minimally Enhanced Usual CarePlacebo Group1 Intervention
Minimally enhanced usual care participants are provided with print educational materials that include a 44-page brochure developed by the National Institute on Aging entitled "A Guide for Older People: Talking with your Doctor" and a blank easy-to-complete advance directive.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,239 Previous Clinical Trials
14,816,253 Total Patients Enrolled
MedStar HealthOTHER
4 Previous Clinical Trials
70,168 Total Patients Enrolled
Johns Hopkins Community PhysiciansOTHER
4 Previous Clinical Trials
66,676 Total Patients Enrolled

Media Library

Sharing Healthcare Wishes in Primary Care (SHARE) Clinical Trial Eligibility Overview. Trial Name: NCT04593472 — N/A
Cognitive Impairment Research Study Groups: Minimally Enhanced Usual Care, SHARE
Cognitive Impairment Clinical Trial 2023: Sharing Healthcare Wishes in Primary Care (SHARE) Highlights & Side Effects. Trial Name: NCT04593472 — N/A
Sharing Healthcare Wishes in Primary Care (SHARE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04593472 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for participants in the current clinical experiment?

"According to information available on clinicaltrials.gov, this medical experiment has resumed recruitment of participants after it was first posted in October 21st 2020 and last edited on October 11th 2022."

Answered by AI

What is the current capacity of participants for this clinical trial?

"Affirmative. Clinicaltrials.gov details that this clinical trial is enlisting participants, beginning with its initial posting on October 21st 2020 and most recently revised on October 11th 2022. This trial needs 248 patients from 10 sites to participate in it."

Answered by AI

How many areas in North America are conducting this medical experiment?

"Currently, 10 different medical trial sites are actively looking for patients to participate in this study. Some of the locations include Olney, Baltimore and Nottingham among other cities. To reduce travel burdens associated with participation, it is recommended that participants choose a site close to their residence."

Answered by AI
Recent research and studies
~62 spots leftby Mar 2025