Quality of Life Clinical Trial
Official title:
myHealthHub for Older Adult Inpatients to Lower Loneliness and Improve Patient Engagement, Quality of Life and Mental Health
Verified date | July 2022 |
Source | Lady Davis Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lady Davis Institute |
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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