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Using Digital Health, Financial Incentives, and Community Health Worker Support to Change Health Behavior
NA trial testing IMPaCT Community Health Worker in Diabetes Mellitus in 150 participants. Completed in 28 July 2020.
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 150 |
| Start date | 15 May 2019 |
| Primary completion | 28 July 2020 |
| Estimated completion | 28 July 2020 |
| Sites | 1 location across United States |
University of Pennsylvania
18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
constructed by summing the number of days in the study period that the glucometer was used divided by the total number of days in study period
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | 65 | ± 28 |
| Digital Health | 70 | ± 25 |
| Hybrid Digital Health and Community Health Worker Support | 72 | ± 29 |
Change in glycosylated hemoglobin from baseline to 6 month follow-up assessment.
| Group | Value | 95% CI |
|---|---|---|
| Usual Care | -0.49 | ± 1.75 |
| Digital Health | -0.85 | ± 1.90 |
| Hybrid Digital Health and Community Health Worker Support | -0.74 | ± 1.66 |
Time frame: Adverse event data was collected for 6 months post-enrollment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Usual Care | Digital Health | Hybrid Digital Health and … |
|---|---|---|---|---|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | — | — | — |
| Hyperglycemia | Endocrine disorders | — | — | — |
| Seizure | Nervous system disorders | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Myocardial Infarction | Cardiac disorders | — | — | — |
| Volume Overload | Cardiac disorders | — | — | — |
| Diabetic Ketoacidosis | Endocrine disorders | — | — | — |
| Hypoglycemia | Endocrine disorders | — | — | — |
| Gastroenteritis | Gastrointestinal disorders | — | — | — |
| Gastroparesis | Gastrointestinal disorders | — | — | — |
| Altered mental status | Nervous system disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Finger infection | Infections and infestations | — | — | — |
| Sepsis | Infections and infestations | — | — | — |
| COVID-19 | Infections and infestations | — | — | — |
| Diabetic foot infection | Infections and infestations | — | — | — |
| Post-operative pain | Injury, poisoning and procedural complications | — | — | — |
| Ankle fracture | Musculoskeletal and connective tissue disorders | — | — | — |
| Subarachnoid hemorrhage | Nervous system disorders | — | — | — |
| Intrauterine fetal demise | Pregnancy, puerperium and perinatal conditions | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — |
| Nephrolithiasis | Renal and urinary disorders | — | — | — |
| Pyelonephritis | Renal and urinary disorders | — | — | — |
| Acute respiratory failure with hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Osteomyelitis, Hyperglycemia, Seizure, Anemia, Myocardial Infarction, Volume Overload, Diabetic Ketoacidosis, Hypoglycemia.
Data from ClinicalTrials.gov NCT03939793 adverse events section.
This randomized controlled trial tests how digital health monitoring with financial incentives (DFI) and community health worker (CHW) support may affect how a person manages their diabetes. Participants will be randomized to one of three arms: 1) DFI intervention, 2) hybrid DFI/CHW intervention, or 3) usual care. Investigators hypothesize that compared to usual care and DFI alone, the hybrid intervention will lead to more glucose self-monitoring and greater improvements in glycosylated hemoglobin.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03939793.
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