273 Participants Needed

SHARE Protocol for Cognitive Impairment

Recruiting at 9 trial locations
DE
Overseen ByDiane Echavarria, MS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the efficacy of Sharing Healthcare Wishes in Primary Care (SHARE), a two-group randomized trial at up to 9 primary care practices in which 124 dyads receive a control protocol of minimally enhanced usual care and 124 dyads receive the SHARE protocol. This study tests the efficacy of SHARE on quality of communication (primary outcome) and advance care planning processes (secondary outcomes) at 6 months among primary care patients with cognitive impairment (mild-severe) and family caregiver dyads. For patients who die while enrolled in the study by 24 months, this study examines the quality of end-of-life care and bereaved family caregiver experiences with medical decision-making (secondary outcomes).

Who Is on the Research Team?

JW

Jennifer Wolff, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am under 80, can make my own health decisions, and plan to stay in-state.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the SHARE protocol or minimally enhanced usual care, focusing on advance care planning and communication

24 months
Enrollment surveys conducted in-person or by telephone or video conference, followed by follow-up surveys at 6, 12, and 24 months

Follow-up

Participants are monitored for quality of communication and advance care planning processes, with additional assessments for bereaved family members if applicable

24 months
Follow-up telephone or web surveys at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Minimally Enhanced Usual Care
  • Sharing Healthcare Wishes in Primary Care (SHARE)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SHAREExperimental Treatment1 Intervention
Group II: Minimally Enhanced Usual CarePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

MedStar Health

Collaborator

Trials
9
Recruited
76,100+

Johns Hopkins Community Physicians

Collaborator

Trials
5
Recruited
66,900+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+
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