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Mobile After-Care Support App: Pilot RCT
NA trial testing Mobile After-Care Support (MACS) app in Psychotic Disorder in 42 participants. Completed in 31 May 2022.
| Lead sponsor | Butler Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 31 May 2019 |
| Primary completion | 31 May 2022 |
| Estimated completion | 31 May 2022 |
| Sites | 1 location across United States |
Butler Hospital
18 and older, any sex, with Psychotic Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 23.7 | ± 4.4 |
| Mobile App Attention Control | 22.5 | ± 7.6 |
The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 53.1 | ± 2.4 |
| Mobile App Attention Control | 49.8 | ± 2.2 |
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 36.4 | ± 2.6 |
| Mobile App Attention Control | 33.1 | ± 2.6 |
The Brief Adherence Rating Scale assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 86.2 | ± 4.8 |
| Mobile App Attention Control | 83.8 | ± 4.4 |
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 94.4 | ± 4.9 |
| Mobile App Attention Control | 92.0 | ± 4.8 |
The Brief Cope Inventory is a 28 item self-report measure of coping skills. The mean values of the 12-item dysfunctional coping subscale was used. Mean scores for the total range from 1-48 with higher scores indicating greater use of the dysfunctional coping strategies.
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 28.6 | ± 1.6 |
| Mobile App Attention Control | 28.1 | ± 1.5 |
| Group | Value | 95% CI |
|---|---|---|
| Mobile After-Care Support (MACS) App | 24.8 | ± 1.7 |
| Mobile App Attention Control | 24.4 | ± 1.7 |
Time frame: 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mobile After-Care Support … | Mobile App Attention Control |
|---|---|---|---|
| Rehospitalization | Psychiatric disorders | — | — |
| Suicide attempt | Psychiatric disorders | — | — |
Most-reported serious reactions: Rehospitalization, Suicide attempt.
Data from ClinicalTrials.gov NCT03955250 adverse events section.
The overall aim of this program of research is to refine and test the feasibility and acceptability of a newly developed mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the app. To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 60), with two treatment arms: MACS vs. a mobile app attention control condition.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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