Clinical Trial Radar

Feasibility: Recruitment

Proportion of potential enrollees who were approached for recruitment.

Through study completion, an average 6 months.

Feasibility: Retention rates

Defined as completing all post-intervention assessments, categorized as a binary outcome Target: ≥75%

Post-intervention at 6-months

Feasibility: Non-Compliance/Adherence

Measured by the proportion of the intervention completed (e.g., number of virtual reality environments viewed out of the total possible available across skill lessons in the intervention). Target: ≥75%

Immediately post-intervention at 5-weeks

Feasibility: Refusal rates

Proportion of potential enrollees who were approached for recruitment but decided not to enroll.

Before enrollment

Acceptability as assessed by whether a participant would recommend the JovialityTM software

Acceptability as measured by whether a participant would recommend JovialityTM to other HD patients (0 definitely not, to 10 definitely yes). Target: ≥8.0

Immediately post-intervention at 5-weeks

Depressive symptoms

Depressive symptomatology will be assessed using the Beck Depression Inventory-II. Scores range from 1 to 40 where a higher score indicates worse symptoms of depression.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Kidney Disease and Quality of Life

Kidney Disease and Quality of Life (KDQOL-SF™). The scoring procedure first transforms the raw precoded numeric values of items to a 0-100 possible range, with higher transformed scores reflecting better quality of life.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Number of missed hemodialysis treatment sessions

Research staff will extract information from patient medical records to record the number of missed hemodialysis treatment sessions

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Emergency department visits and/or hospitalizations

Research staff will extract information from patient medical records to record the number of emergency department visits and days of hospitalizations.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms

The Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test for depressive symptoms (range values: 28- 140) will serve as an additional measure to triangulate findings of the Beck Depression Inventory-II. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for anxiety

The PROMIS adaptive measures for anxiety (range values: 29-145) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for perceived stress

The PROMIS adaptive measures for perceived stress (range values: 29-145) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for life satisfaction

The PROMIS adaptive measures for life satisfaction (range values: 10-60) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for positive affect

The PROMIS adaptive measures for positive affect (range values: 34-170) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for life meaning and purpose

The PROMIS adaptive measures for life meaning and purpose (range values 4-60) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Patient-Reported Outcomes Measurement Information System (PROMIS) for self-efficacy for managing emotions in the context of a chronic condition

The PROMIS adaptive measures for self-efficacy for managing emotions in the context of a chronic condition (range values: 25-125) will be used. A higher PROMIS T-score represents more of the concept being measured.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Psychological well-being measured with the 7-item State Optimism Measure

Additional measures of psychological well-being will include the optimism using the 7-item State Optimism Measure. Scoring is mean score of items 1-7 with a higher score indicating greater state optimism.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Psychological well-being measured with the Emotional Vitality Measure

Additional measures of psychological well-being will also include emotional vitality (range values 0-110), as measured using select items of the General Well-being Schedule. There are three proposed cut-points: total scores of 0-60 reflect "severe distress", 61-72 "moderate distress" and 73-110 "positive well-being"

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)

Psychological well-being measured with the Flourishing Index

The "Flourish" measure is obtained by summing the scores from each of the first five domains. The "Secure Flourish" measure is obtained by summing the scores from all six domains including the financial and material stability domain. Each of the questions is assessed on a scale of 0-10. The secure flourishing index score is obtained by summing the scores from the twelve questions in all six domains and results in a score from 0 - 120. Often, for purposes of interpretation, the flourishing and secure flourishing scores are reported as averages of the questions (rather than sums) so that all scores are on a scale of 0-10.

Baseline, immediately post-intervention (5-weeks) and at follow-up (3- and 6-months post-intervention)