myHealthHub for Older Adult Inpatients

July 5, 2022 updated by: Soham Rej MD, MSc, Lady Davis Institute

myHealthHub for Older Adult Inpatients to Lower Loneliness and Improve Patient Engagement, Quality of Life and Mental Health

This study will assess "myHealthhub" in hospitalized older adults throughout 5 days of their hospital stay. The investigators propose a mixed method randomized controlled trial (RCT) comparing myHealthHub platform vs. a simplified HealthHub system that provides only TV access, in order to evaluate patients' loneliness, stress, quality of life, patient engagement, and other mental health outcomes in n=60 older adult inpatients. The investigators will also use qualitative methods to assess user and stakeholder experience, and engagement.

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Quantitative Component:

Inclusion Criteria:

  • ≥60 years old
  • Admitted to non-surgical hospital unit
  • Speak English or French
  • Capable of giving consent

Exclusion Criteria:

  • Delirium
  • Active suicidal ideation
  • Moderate/severe dementia diagnosis

Qualitative Component:

Inclusion Criteria:

  • Participants from quantitative component
  • Hospital staff, nurses, clinicians facilitative use of the service
  • ≥18 years old
  • Speak English or French

Exclusion Criteria:

• Hospital staff, nurses, clinicians who do not have experience with the service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: myHealthHub
myHealthHub is a multimodal patient engagement platform delivered on bedside terminals to provide hospital inpatients with social connection, meal ordering services, entertainment (TV, etc.), and access to medical care team.
Active Comparator: Active control: TV-only
myHealthHub device equipped with the TV-only entertainment option.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Loneliness
Time Frame: Baseline, day 2, day 3, day 4, day 5
Loneliness measured by the UCLA 3-item Loneliness Scale (UCLA-3). This is a 3-item scale with scores ranging from 3-9, with higher scores indicating greater severity of loneliness.
Baseline, day 2, day 3, day 4, day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Stress
Time Frame: Baseline, day 3, day 5
Stress measured by Perceived Stress Scale (PSS). This is a 14-item scale with scores ranging from 0-56, with higher scores indicating greater severity of stress.
Baseline, day 3, day 5
Changes in Patient Engagement
Time Frame: Baseline, day 3, day 5
Patient engagement measured by Patient Activation Measure-13 (PAM-13). This is a 13-question scale.
Baseline, day 3, day 5
Changes in Quality of Life in Older Adults
Time Frame: Baseline, day 3, day 5
Quality of life which will be measured by the Euro-Quality of Life (EQ-5D). This is a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Baseline, day 3, day 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Outcome: Enrollment
Time Frame: Day 5
Enrollment rate (percent of participants enrolled from eligible participants)
Day 5
Feasibility Outcome: Recruitment
Time Frame: Day 5
Recruitment target (ability to recruit 60 participants)
Day 5
Feasibility Outcome: Retention
Time Frame: Day 5
Retention rate (percent of randomized participants who complete 5-day assessments in both arms)
Day 5
Exploratory Outcome: Changes in Depression
Time Frame: Baseline, day 5
Depression measured by the Patient Health Questionnaire-9 (PHQ-9). This is a 9-question scale with scores ranging from 0-27, with higher scores indicating greater severity of depression.
Baseline, day 5
Exploratory Outcome: Changes in Anxiety
Time Frame: Baseline, day 5
Anxiety measured by Generalized Anxiety Disorder-7 (GAD-7) scale. This is a 7-question scale with scores ranging from 0-21, with higher scores indicating greater severity of anxiety.
Baseline, day 5
Qualitative Component: Semi-structured interviews
Time Frame: Day 5
The qualitative outcome of this RCT will analyze the experiences, barriers, and engagement of older adults with the myHealthHub device. It will also explore the experiences and limitations of hospital support staff with myHealthHub service.
Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-619

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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