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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05450445
Other study ID # 2023-619
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2023

Study information

Verified date July 2022
Source Lady Davis Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
TV-only
myHealthHub device equipped with the TV-only entertainment option.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lady Davis Institute

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility Outcome: Enrollment Enrollment rate (percent of participants enrolled from eligible participants) Day 5
Other Feasibility Outcome: Recruitment Recruitment target (ability to recruit 60 participants) Day 5
Other Feasibility Outcome: Retention Retention rate (percent of randomized participants who complete 5-day assessments in both arms) Day 5
Other Exploratory Outcome: Changes in Depression 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
Other Exploratory Outcome: Changes in Anxiety 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
Other Qualitative Component: Semi-structured interviews 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
Primary Changes in Loneliness 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 Changes in Stress 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
Secondary Changes in Patient Engagement Patient engagement measured by Patient Activation Measure-13 (PAM-13). This is a 13-question scale. Baseline, day 3, day 5
Secondary Changes in Quality of Life in Older Adults 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
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