| Protocol ID | NCT04203147 |
| Registration Date | 2019-12-18 |
| Status | completed |
| Sponsor | State University of New York at Buffalo |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-01-03 |
| Last Patient Out | 2026-01-01 |
| Publication | y |
| Gender % | ALL |
| Mean Age | 65 Years - |
NCT04203147
HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
| Field |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4914ms / 10081 tok |
GLM
glm-5.1 6318ms / 8823 tok |
OPENAI
gpt-4o Thinking: o3 3445ms / 8679 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 | home care | home care | home care | 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 | yes | yes | yes | OK |
| intervention_complex |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The Home DM-BAT intervention combines multiple distinct components including behavioral activation therapy, diabetes education/skills training, and social determinants of health interventions delivered together as an integrated treatment.
|
yes |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention includes both diabetes education/skills training and behavioral activation, which are distinct components from different categories.
|
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 | no | yes | – |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The brief summary explicitly states the objective is to evaluate both efficacy and cost-effectiveness of the Home DM-BAT intervention.
|
yes |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study evaluates the cost-effectiveness of the Home DM-BAT intervention, indicating a focus on economic outcomes.
|
OK |
| outcome_other |
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The only outcome measured is glycemic control (HbA1c), which falls under the symptom/clinical category.
Thinking: yes — The primary outcome is glycemic control (HbA1c), which is a clinical biomarker not covered by symptom/QoL/dignity/cost categories.
|
yes |
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial includes evaluating the cost-effectiveness of the intervention, which does not fall under symptom, QoL, dignity, or cost categories.
Thinking: yes — Primary outcome is glycemic control (HbA1c), a biomarker not belonging to symptom, quality-of-life, dignity, or cost categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |