- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05450445
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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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