Increasing Caregiver and Patient Engagement Through PHR Use

NCT03659565 | Terminated

• 1 other identifier: 0491-18-EP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Informal caregivers play an integral role in managing complex, chronic disease patients providing services equivalent to an estimated economic value of $470 billion. The inclusion of informal caregivers in the healthcare team can improve care coordination and make health care safer by reducing potential medical errors caused by miscommunication. the investigators reason that a properly designed PHR with a simplified user interface and easy access to relevant content can improve the management of chronic diseases and better integrate caregivers and patients into the healthcare team.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Patient activation

  Patient activation will be measured using Altarum Consumer Engagement (ACE) Measure™. The ACE survey is a 21-item survey that measures patient engagement and health consumerism.

  12 months

• Caregiver activation

  Caregiver activation will be measured using the Family Caregiver Activation in Transitions (FCAT) Tool. FCAT is a 10-item tool used to measure caregivers' activation and self-efficacy.

  12 months

Secondary Outcomes (3)

• Medication adherence

  12 months

• Caregiver Satisfaction

  12 months

• Patient Satisfaction

  12 months

Study Arms (2)

Enhanced Pre-Visit Consultation

EXPERIMENTAL

Patients and caregivers will participate in an enhanced pre-visit consultation using Zoom for remote video and audio conferencing with screen sharing capabilities.

Behavioral: Enhanced Pre-Visit Consultation

Usual Care Control

ACTIVE COMPARATOR

Patients continue to receive usual care from their cardiologist.

Behavioral: Usual Care Control

Interventions

Enhanced Pre-Visit Consultation BEHAVIORAL

The Intervention Group will be given access to the optimized personal health record and will use Zoom as part of the pre-visit consultation.

Enhanced Pre-Visit Consultation

Usual Care Control BEHAVIORAL

Caregivers and patients will participate in usual pre-visit process.

Usual Care Control

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will be patients with heart disease, able read, write, and speak English, and at least 65 years of age.
• Eligible caregivers will be a primary caregiver of an eligible patient, able to read, write, and speak English, and at least 18 years of age.

You may not qualify if:

• Individuals under the age of 19 will not be considered for participation.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Martina Clarke, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: September 6, 2018
• Study Start: April 23, 2019
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)