Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
NCT07916753, Not applicable, Not yet recruiting, Fondation Net-Care.ch
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition | ClinicalTrials.gov |
| NCT number | NCT07916753 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondation Net-Care.ch | ClinicalTrials.gov |
| Conditions | Hypertension, Diabetes Mellitus, Type 2, Obesity | ClinicalTrials.gov |
| Interventions | SOFIA application | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | User Retention: Proportion of Participants With Sustained Inactivity (Attrition) | From registration up to 13 months | Attrition (proportion of participants), with sustained inactivity defined as no session for 90 consecutive days. Success criterion: attrition \<20%. | ClinicalTrials.gov |
| Primary | Acceptability: French System Usability Scale (F-SUS) Score | Approximately every 90 days from registration, up to 13 months | Marginal mean French System Usability Scale (F-SUS; 10 items) score across administrations. Score 0-100; higher scores indicate better usability. Success criterion: \>68. | ClinicalTrials.gov |
| Secondary | Satisfaction and Perceived Utility: Item Scores | Approximately every 90 days from registration, up to 13 months | Item-level distributions across administrations (two study-specific items: overall satisfaction and perceived utility; 5-point Likert scale, 1-5; higher scores indicate greater satisfaction or perceived utility). | ClinicalTrials.gov |
| Secondary | Willingness to Recommend: Net Promoter Score (NPS) | Approximately every 90 days from registration, up to 13 months | Net Promoter Score (NPS; 1 item, 0-10 per respondent; higher scores indicate greater willingness to recommend). NPS = percentage of promoters minus percentage of detractors; range -100 to +100, higher is better. | ClinicalTrials.gov |
| Secondary | Physical Activity: IPAQ-SF Score (MET-minutes/week) | Approximately every 180 days from registration, up to 13 months | Score trajectory across administrations (International Physical Activity Questionnaire - Short Form, IPAQ-SF; 7 items). Total physical activity in MET-minutes/week; minimum 0, no fixed maximum; higher values indicate more physical activity. | ClinicalTrials.gov |
| Secondary | Sleep Quality: Pittsburgh Sleep Quality Index (PSQI) Global Score | Approximately every 180 days from registration, up to 13 months | Score trajectory across administrations (Pittsburgh Sleep Quality Index, PSQI). Global score 0-21; higher scores indicate worse sleep quality. | ClinicalTrials.gov |
| Secondary | Well-Being: WHO-5 Well-Being Index Score | Approximately every 90 days from registration, up to 13 months | Score trajectory across administrations (World Health Organization Well-Being Index, WHO-5; 5 items). Raw score 0-25; higher scores indicate better well-being. | ClinicalTrials.gov |
| Secondary | Self-Rated Health (SRH) Score | Approximately every 90 days from registration, up to 13 months | Score trajectory across administrations (Self-Rated Health, SRH; 1 item). Score 1-5 (1 = excellent, 5 = poor); higher scores indicate worse self-rated health. | ClinicalTrials.gov |
| Secondary | Perceived Stress: Perceived Stress Scale (PSS-4) Score | Approximately every 90 days from registration, up to 13 months | Score trajectory across administrations (Perceived Stress Scale, 4-item version, PSS-4). Score 0-16; higher scores indicate greater perceived stress. | ClinicalTrials.gov |
| Secondary | Quality of Life: Global Quality of Life Scale Score | Approximately every 90 days from registration, up to 13 months | Score trajectory across administrations (Global Quality of Life Scale; 1 item). Score 0-100; higher scores indicate better quality of life. | ClinicalTrials.gov |
| Secondary | Self-Efficacy for Chronic Disease Management: SEM-CD 6 Score | Approximately every 180 days from registration, up to 13 months | Score trajectory across administrations (Self-Efficacy for Managing Chronic Disease 6-Item Scale, SEM-CD 6). Mean score 1-10; higher scores indicate greater self-efficacy. | ClinicalTrials.gov |
| Secondary | Condition-Specific Health Knowledge: Percentage of Correct Answers (Condition Subgroups) | At registration and approximately 6 months after registration | Change in percentage of correct answers on a health knowledge quiz (0-100%; higher values indicate better knowledge). | ClinicalTrials.gov |
| Secondary | Medication Tracking: Data Matrix Scan Confirmation Rate (Pochettes-Doses Users) | Continuously from registration, up to 13 months | Data matrix scan confirmation rate (proportion). | ClinicalTrials.gov |
| Secondary | Medication-Tracking Gaps: Proportion of Missed or Mistimed Scan Events (Condition Subgroups) | Continuously from registration, up to 13 months | Proportion of missed or mistimed scan events among actively engaged pochettes-doses users. | ClinicalTrials.gov |
| Secondary | Self-Reported Medication Adherence: Visual Analogue Scale (VAS) Score (Condition Subgroups) | Approximately every 90 days from registration, up to 13 months | Score trajectory across administrations (medication adherence visual analogue scale, VAS; 1 item). Score 0-100; higher scores indicate better adherence. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)