| Protocol ID | NCT04491253 |
| Registration Date | 2020-07-29 |
| Status | completed |
| Sponsor | Universidad de Antioquia |
| Country | Colombia |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2021-09-13 |
| Last Patient Out | 2022-02-18 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 99 Years |
NCT04491253
Efficacy of a Social Support Intervention in Adults for Self-management of Type 2 Diabetes Mellitus
| Field |
GLM
glm-5.1 6785ms / 8687 tok |
OPENAI
gpt-4o 2586ms / 8537 tok |
CLAUDE
claude-sonnet-4-20250514 4987ms / 9902 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
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a social support and educational strategy to promote self-management, lacking a named or structured psychological therapeutic approach such as CBT or psychotherapy.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is described as a social support intervention focusing on informational, instrumental, and emotional support for diabetes self-management, without mentioning any structured psychological therapy.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention focuses on social support (informational, instrumental, and emotional support) but does not specify a structured psychological therapy approach like CBT, ACT, or psychotherapy.
|
OK |
| intervention_complex |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention, although it includes multiple components of social support, is classified as a single behavioral modality focused on diabetes self-management.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a single behavioral intervention focused on social support with multiple components (informational, instrumental, emotional) but all within the same social support framework rather than combining distinct intervention types.
|
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 | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The primary and secondary outcomes in this trial measure self-management behaviors and social support using the Nursing Outcomes Classification, which do not include specific symptom measures like pain, anxiety, or depression using the specified instruments.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures self-management behaviors and social support using NOC (Nursing Outcomes Classification) scales, which are not validated symptom-specific instruments for pain, nausea, dyspnea, fatigue, anxiety, depression, or other specific symptoms.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |