Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial
Authors' conclusion
In this randomized clinical trial of telephone-based layperson-delivered empathetic engagement, patients with diabetes and low income achieved clinically meaningful improvements in glycemic control. With workforce constraints, layperson-delivered programs for diabetes show promise.
Study context
- Population
- Patients with uncontrolled diabetes from a federally qualified health center in Austin, Texas; mean (SD) age 49.5 (10.1) years; 62.9% women; 86.7% annual income <$40,000204 measured at 6 months
- Participants
- 260 patients
- Comparison
- Layperson-delivered empathy-oriented telephone calls vs usual care
- Primary endpoint
- HbA1c at baseline, 3 and 6 months, assessed for interaction between time and trial arm
- Follow-up
- 6 months
Methodological detailsparallel-arm, blinded outcome assessment, stratified by baseline Patient Health Questionnaire (PHQ-9) score (≥5 vs <5), Conducted February 12, 2022, to April 15, 2023; final measurements November 18, 2023
- Parallel-arm
- Blinded outcome assessment
- Stratified by baseline PHQ-9 score (≥5 vs <5)
- Conducted February 12, 2022, to April 15, 2023; final measurements November 18, 2023
Primary result
As reported in the abstract
HbA1c, mean (SD) change from baseline
| Group | Value | Baseline | Within-person change |
|---|---|---|---|
| Intervention | mean 9.3% (SD 2.0%) | 10.0% [1.9%] | −0.7% (95% CI, −1.0% to −0.4%) |
| Control | mean 9.7% (SD 2.3%) | 9.8% [1.6%] | 0.02% (95% CI, −0.4% to 0.4%) |
Value
Interventionmean 9.3% (SD 2.0%)
Controlmean 9.7% (SD 2.3%)
Baseline
Intervention10.0% [1.9%]
Control9.8% [1.6%]
Within-person change
Intervention−0.7% (95% CI, −1.0% to −0.4%)
Control0.02% (95% CI, −0.4% to 0.4%)
- Intervention vs Control: P = 0.004 — significant decrease with intervention
Secondary outcomes
Returned for 6-month measurements
| Outcome | Intervention | Control | P value |
|---|---|---|---|
| HbA1c within-person change, subgroup PHQ-9 ≥5 (38.1% [99 of 260]) · 6 months | −1.1% (95% CI −1.8%–-0.5%) | 0.1% (95% CI −0.7%–0.8%) | P = 0.004 |
| HbA1c within-person change, subgroup PHQ-9 <5 · 6 months | −0.4% (95% CI −0.8%–-0.1%) | −0.02% (95% CI −0.5%–0.5%) | P = 0.21 |
- Returned for 6-month measurements: 204 of 254 (80.3%) overall; 6 withdrew
Program rated very or extremely beneficial · 6 months
- Participants rating program very or extremely beneficial
- 91.7% (99 of 108)
Original publication
Glycemic Control With Layperson-Delivered Telephone Calls vs Usual Care for Patients With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. Published 2 December 2024. doi:10. 1001/ jamanetworkopen. 2024. 48809
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