Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Acceptability |
usability assessment that we adapted from this original source: Questionnaire for User Interface Satisfaction. Based on: Lund, A.M. (2001) Measuring Usability with the USE Questionnaire. STC Usability SIG Newsletter, 8:2; constructs assessed: usefulness, ease of use, ease of learning, satisfaction. Responses can range from 1 to 7, and scores represent an average of responses so can also range from 1 to 7, with higher scores representing greater acceptability. |
4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Social Isolation |
PROMIS Social Isolation -Short Form 8a: The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others; scores represent T-scores, with a higher score representing higher levels of social isolation. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 55-60 represents mild social isolation, 60-70 represents moderate, and >70 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Anxiety |
General Anxiety Disorder Scale (GAD-7): Total score (adding all the numbers) provides a possible score from 0-21, higher scores reflect more anxiety. |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Self Efficacy for Managing Social Interactions |
PROMIS Self Efficacy for Managing Social Interactions -Short Form 4a: : Confidence in participating in social activities and getting help when necessary. Managing communication with others about their medical condition, including communication with health professionals. Scores represent T-scores, with higher scores representing higher self-efficacy. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low self-efficacy and <30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Companionship |
PROMIS Companionship -Short Form 4a: The PROMIS adult Companionship item bank assesses perceived availability of someone with whom to share enjoyable social activities such as visiting, talking, celebrations, etc. Scores represent T-scores, with higher scores representing higher levels of companionship. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low companionship and <30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Ability to Participate in Social Roles and Activities |
PROMIS Ability to Participate in Social Roles and Activities -Short Form 4a: Scores represent T-scores, with higher scores representing a higher perceived ability to participate. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 40-45 represents mild difficulty in participating, 30-40 represents moderate, and <30 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Depression |
Geriatric Depression Scale (GDS) - Short Form: scores range from 1 to 15, with higher scores reflecting more depressive symptoms. |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Functional Status |
PROMIS-Physical function 8b: PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. Scores represent T-scores, with higher scores representing higher levels of physical function. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 40-45 represents mild physical function concerns, 30-40 represents moderate, and <30 represents severe (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Cognitive Function |
Brief Montreal Cognitive Assessment (MoCA): The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 22, with higher scores representing higher cognitive function. A score of 18 or higher is considered "normal" cognition. |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
| Primary |
Change in Well-being |
Neuro-QOL Positive Affect & Well-Being: Scores represent T-scores, and higher scores indicate better self-reported well-being. T-score of 50 indicates the population mean, with a standard deviation of 10. In terms of cut points, a T-score of 30-40 represents low positive affect and <30 represents very low (https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/promis-score-cut-points). |
baseline, 4 weeks, 8 weeks, and 16 weeks |
|
