Clincosm LogoSign in Get a demo

myHealthHub for Older Adult Inpatients

Sponsor
Lady Davis Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05450445
Collaborator
(none)
60
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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
  • Device: myHealthHub
  • Device: TV-only
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Changes in Loneliness [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 [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 [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 [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 [Day 5]

    Enrollment rate (percent of participants enrolled from eligible participants)

  2. Feasibility Outcome: Recruitment [Day 5]

    Recruitment target (ability to recruit 60 participants)

  3. Feasibility Outcome: Retention [Day 5]

    Retention rate (percent of randomized participants who complete 5-day assessments in both arms)

  4. Exploratory Outcome: Changes in Depression [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 [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 [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

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Lady Davis Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Soham Rej MD, MSc, Principal Investigator, Lady Davis Institute
ClinicalTrials.gov Identifier:
NCT05450445
Other Study ID Numbers:
  • 2023-619
First Posted:
Jul 8, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
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, Principal Investigator, Lady Davis Institute
Older adults
Hospital Inpatients
Technology

Study Results

No Results Posted as of Jul 8, 2022