The Impact of the Family Room App on Caregivers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

Engaging families in patient care during serious illness can enhance care quality, reduce social isolation, boost satisfaction, and lower healthcare costs. However, active involvement of family caregivers remains limited because there are no evidence-based tools to guide clinicians on how to include them effectively. This study will test and refine previously developed point-of-care application, Family Room, and determine its effectiveness by comparison with a control group. A series of surveys will be used to evaluate caregiver well-being, engagement and satisfaction.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

19 years of age or older

Present at participant's bedside during the intensive care unit (ICU) admission

Participant's legally authorized representative (LAR) or designated caregiver to make medical decisions on their behalf

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Family Room Application

    Device

    The Family Room application is a point of care tool that guides families on contributing to patient participant care by providing real time education, a sense of connection, emotional support, and resources that enable meaningful care giving. Importantly, family caregiver participants receive virtual training on comfort-focused care activities that can be done at the bedside, as well as a mechanism within the electronic health record (EHR) to measure and record the effectiveness of the care they provide.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control Group - No InterventionNo intervention 0 interventions
Group B: Intervention Group - Family Room ApplicationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Caregiver Engagement - Practical Aspects: FAMily Engagement (FAME) Tool

The FAMily Engagement (FAME) questionnaire is a self-rated instrument developed to assess current family engagement. Questions address key principles of family-centered care, such as dignity and respect, information sharing, participation, and collaboration. They also address family engagement domains, including family presence, family needs, communication and education, decision making, and direct care. A five-point Likert scale (1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree) is used for responses, which are transformed to a 0-100 scoring system by dividing the sum of the scores by the number of questions answered. Higher scores indicate greater engagement in care and lower scores indicating lesser engagement.

Time frame
At study enrollment and within 48 hours of patient participant ICU discharge
2

Daily Activity: Family Room Application

The daily activity logged in the Family Room application at bedside is assessed (intervention group only).

Time frame
Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
3

Daily Patient Symptoms - Severity of Illness: Acute Physiology and Chronic Health Evaluation (Apache II)

APACHE II (Acute Physiology and Chronic Health Evaluation II) is a severity-of-disease classification system used in the ICU. An integer score is assessed by medical staff from 0 to 71 is computed based on several measurements. Higher scores correspond to more severe disease and a higher risk of death. Information is taken from the electronic health record.

Time frame
Daily from enrollment until patient participant ICU discharge, an average of 3 weeks
4

Daily Patient Symptoms: Presence of Lines, Tubes and Equipment

A daily count of number of lines, tubes and equipment present on ICU patient participant is taken. Information is taken from the electronic health record.

Time frame
Daily from enrollment until patient participant ICU discharge, an average of 3 weeks

Secondary outcomes

1

Caregiver Well-being: Screening Tool for Psychological Distress (STOP-D)

This is a self-rated 5 item instrument which provides severity scores for each of the common psychosocial problem areas: depression, anxiety, stress, anger, and low social support. Scoring is "0" (not at all) to "9" (severely). The higher the score the greater the psychological distress.

Time frame
At study enrollment, every 48 hours while patient participant is in the ICU, and within 48 hours of patient participant ICU discharge
2

Caregiver Well-being: Caregiver Self-Assessment Questionnaire

This is a self-rated 18-item instrument devised by the American Medical Association for physicians to assess the stress-levels of family caregivers. Caregivers are asked to respond either "Yes" or "No" to a series of statements, simple scoring system allows family caregiver themselves to score their results and to determine whether or not they are highly stressed. Points are added for each 'yes' answer for 16 questions plus a 1 to 10 score for a question of current stress levels and for a question on comparing perceived current health compared to a year ago. A higher number means more stress.

Time frame
At study enrollment and within 48 hours of patient participant ICU discharge
3

Caregiver Engagement - Psychological Experience: Caregiving Health Engagement Scale (CHE-s)

This is a self-rated 7 item multidimensional instrument to evaluate the impact of burden on different aspects of a caregiver's life. Caregivers respond to a series of statements, indicating their level of agreement or disagreement. The CHE is scored based on a Likert-type scale. The total score reflects the caregiver's overall engagement in healthcare. Higher scores indicate greater engagement.

Time frame
At study enrollment and within 48 hours of patient participant ICU discharge
4

Caregiver Resilience: Connor-Davidson Resilience Scale (CD-RISC2)

This is a self-rated 2 item instrument that measures resilience as it relates to ability to thrive in the face of adversity. Answers are on a 5-point scale, not true at all=0, rarely true=1, sometimes true=2, often true=3, and true nearly all of the time=4. Higher scores indicating greater perceived resilience.

Time frame
At study enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Gordon and Betty Moore Foundation

Collaborator