| Protocol ID | NCT03394456 |
| Registration Date | 2018-01-09 |
| Status | completed |
| Sponsor | Baylor College of Medicine |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2018-01-13 |
| Last Patient Out | 2022-08-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT03394456
Technology to Improve the Health of Resource-poor Hispanics With Diabetes
| Field |
CLAUDE
claude-sonnet-4-20250514 5257ms / 11191 tok |
OPENAI
gpt-4o 2533ms / 9627 tok |
GLM
glm-5.1 5668ms / 9863 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention combines multiple distinct components including CHW-led group visits, telehealth support/training, mobile health contact, and comprehensive diabetes education that interact together as an integrated care delivery system.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines telehealth-supported CHW-led group visits and telehealth training for CHWs, integrating educational and behavioral components with technological support, qualifying as a multi-component complex intervention.
|
yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This diabetes management study focuses on clinical outcomes, treatment adherence, and patient satisfaction, with only brief mention of faith/spirituality in a general satisfaction survey rather than measuring dignity, meaning, or existential well-being as primary constructs.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on diabetes management and does not measure dignity, spirituality, meaning, or existential well-being using relevant instruments.
|
no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |