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myHealthHub for Older Adult Inpatients

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ClinicalTrials.gov Identifier: NCT05450445
Recruitment Status : Not yet recruiting
First Posted : July 8, 2022
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Soham Rej MD, MSc, Lady Davis Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Engagement Stress Loneliness Quality of Life Device: myHealthHub Device: TV-only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: myHealthHub for Older Adult Inpatients to Lower Loneliness and Improve Patient Engagement, Quality of Life and Mental Health
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention: myHealthHub Device: 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 Device: TV-only
myHealthHub device equipped with the TV-only entertainment option.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. Feasibility Outcome: Enrollment [ Time Frame: Day 5 ]
    Enrollment rate (percent of participants enrolled from eligible participants)

  2. Feasibility Outcome: Recruitment [ Time Frame: Day 5 ]
    Recruitment target (ability to recruit 60 participants)

  3. Feasibility Outcome: Retention [ Time Frame: Day 5 ]
    Retention rate (percent of randomized participants who complete 5-day assessments in both arms)

  4. 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.

  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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Soham Rej MD, MSc, Principal Investigator, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT05450445    
Other Study ID Numbers: 2023-619
First Posted: July 8, 2022    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soham Rej MD, MSc, Lady Davis Institute:
Older adults
Hospital Inpatients
Technology