Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Recruitment and retention: Number of interested participants |
Calculate the total number of participants contacting the study team to express an interest in taking part in the study. |
5month recruitment period |
|
| Primary |
Recruitment and retention: Number of eligible participants |
Calculate the total number of participants contacting the study team to express an interest in taking part in the study who are eligible to take part. Calculate this as a percentage of total number of interested participants. |
5month recruitment period |
|
| Primary |
Recruitment and retention: Response rate |
Calculate the total number of eligible participants who went onto complete the consent form. Calculate this as a percentage of total number of eligible participants. |
5month recruitment period |
|
| Primary |
Recruitment and retention: One month follow up retention rates |
Calculate the total number of participants enrolled onto the study who went onto complete the 1month follow up. Calculate this as a percentage of total number of enrolled participants. |
Baseline plus 1 months (28 days), end of trial period |
|
| Primary |
Recruitment and retention 4: Three month follow up retention rates |
Calculate the total number of participants enrolled onto the study who went onto complete the 3month follow up. Calculate this as a percentage of total number of enrolled participants. |
Baseline plus 3 months (84 days) |
|
| Primary |
Recruitment and retention 5: Comparability of sample to MOD personnel |
Comparability of sample to Ministry of Defence statistics for major sub-groups of veterans (age, service branch, rank) |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: Technical delivery |
Evaluation of the technical delivery of the app was gained through gathering feedback from developers and participants, identifying any potential technical issues |
Baseline plus 1 months (28 days), end of trial period |
|
| Primary |
Trial procedures and outcome measures: GHQ12 |
The General Health Questionnaire (GHQ-12) is a measure of common mental disorders such as anxiety and depression. It is a 12-item self-report questionnaire measured on a 4-point scale. Scores range from 0-12 with a score of 4 or more indicative of probable mental ill health.The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated. |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: PCL-C |
To evaluate symptoms of PTSD, the PTSD Checklist Civilian version (PCL-C) was used. It is a 17-item self-report questionnaire, measured on a 5-point scale from (1) not at all to (5) extremely. Scores range from 17 to 85, scores over 50 are indicative of possible PTSD. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated. |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: Well-being |
Warwick Edinburgh Mental Well-being Scale (WEMWBS) measures mental well-being within the previous two weeks and is a 14-item self-report questionnaire measured on a 5-point scale from (1) none of the time to (5) all of the time. Scores range from 14 to 70 with higher scores indicative of greater mental well being. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated. |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: WHO QOL-BREF |
Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report questionnaire divided into four domains: physical health; social relationships; psychological health; environmental health. It is measured on a 5-point scale, with a score of 0-100 calculated, where 100 equates to the best possible state of health. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated. |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: Completion rates |
Examination of the feasibility of using the app to collection outcome measures was assessed via completion rates for each of the questionnaires (baseline; 1month follow up; 3month follow up) |
Baseline plus 3 months (84 days) |
|
| Primary |
Trial procedures and outcome measures: Sample size |
Sample size estimates for a future randomised control trial were assessed via changes in GHQ12 scores from baseline to 3month follow up. |
Baseline plus 3 months (84 days) |
|
| Primary |
Acceptability and usability: Usage |
App usage data were collected from Google Analytics via Firebase (CA, USA) and included information such as the number of times the app was opened, the duration of each app use and the number of times specific sections of the app were used. |
Baseline plus 1 month (28 days), end of initial trial period |
|
| Primary |
Acceptability and usability: MAUQ |
The mHealth App Usability Questionnaire (MAUQ) was used to assess app usability at day 28. A 16 item version of the MAUQ of the self-report questionnaire was used, measured on a 7-point scale ranging from strongly disagree (1) to strongly agree (7). Participant responses were aggregated into overall usability and three other domains: ease of use and satisfaction, interface and functionality, and usefulness. The mean total score and the mean of each three domains were scored out of seven, with a score of four indicating a neutral response and higher scores indicating greater app usability. |
Baseline plus 1 month (28 days), end of initial trial period |
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