Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
use of the online tool, by means of time logged in |
time spent logged in (minutes) |
up to 10 weeks |
|
Primary |
use of the online tool, by means of number of log-ins |
number of log-ins (number) |
up to 10 weeks |
|
Primary |
use of the online tool, by means of number of lesson/modules started |
number of modules started (number) |
up to 10 weeks |
|
Primary |
use of the online tool, by means of number of exercises completed |
number of exercises completed (number) |
up to 10 weeks |
|
Primary |
usability of the online tool, by means of the System Usability Scale (SUS), when participant completes the program |
the system usability scale, the SUS, total score |
through study completion, after each module (up to 10 wks) |
|
Primary |
usability of the online tool, by means of the System Usability Scale (SUS) when participant no longer logs in and after invitation through email reminder |
the system usability scale, the SUS, total socre |
2 weeks |
|
Primary |
usability of the online tool, by means of an open-ended qualitative question when participant completes the program. |
a qualitative open question |
through study completion, after each module (up to 10 wks) |
|
Primary |
usability of the online tool, by means of an open-ended qualitative question, when participant no longer logs in and after invitation through email reminder |
a qualitative open question |
2 weeks |
|
Primary |
patient satisfaction, by means of qualitative questions when participant completes the program |
qualitative questions (Likert scale) |
through study completion, after each module (up to 10 wks) |
|
Primary |
patient satisfaction, by means of open-ended qualitative questions, when participant completes the program |
qualitative questions (open-ended) in-depth questions |
through study completion, after each module (up to 10 wks) |
|
Primary |
patient satisfaction, by means of qualitative questions when participant no longer logs in, and after invitation through email reminder |
qualitative questions (Likert scale) |
2 weeks |
|
Primary |
patient satisfaction, by means of open-ended qualitative questions when participant no longer logs in and after invitation through email reminder |
qualitative questions (open-ended) in-depth questions. |
2 weeks |
|
Secondary |
reduction of depressive, anxiety and stress symptoms as pre-measurement |
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder. |
baseline |
|
Secondary |
reduction of depressive, anxiety and stress symptoms as post-measurement |
DASS 21-R, total score and scores of depressive scale (normal [0-9], mild [10-13], moderate [14-20], severe [21-27], extremely severe [28+]); anxiety scale (normal [0-7], mild [8-9], moderate [10-14], severe [15-19], extremely severe [20+]); stress scale (normal [0-14], mild [15-18], moderate [19-25], severe [26-33], extremely severe [34+]); Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder. |
study completion (up to 10 weeks) |
|
Secondary |
reduction of depressive and anxiety symptoms as pre-measurement |
EPDS, total score (continuous and cut-off >= 13); EDS-3A(3 anxiety questions) (continuous and cut-off >= 5) |
baseline |
|
Secondary |
reduction of depressive, and anxiety symptoms as post-measurement |
EPDS total score (continuous and cut-off >= 13); EDS-3A (3 anxiety questions)(continuous and cut-off >= 5) |
study completion (up to 10 weeks) |
|