N/A
Completed N=444
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support
Diabetes · High Blood Pressure · High Blood Sugar · Hypertension
Source: ClinicalTrials.gov NCT03812614 ↗
Enrolled (actual)
444
Serious AEs
8.6%
Results posted
Feb 2025
Primary outcomePrimary: Change From Baseline in Patient Glycemic Control at 6 Months — -0.43; -0.97 percentage — p=0.07
Summary
The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Patient Glycemic Control at 6 Months |
-0.43; -0.97 | 0.07 |
| SECONDARY Change From Baseline in Patient Glycemic Control at 12 Months |
-0.67; -0.65 | 0.96 |
| SECONDARY Change From Baseline in Patient Systolic Blood Pressure at 6 Months |
-0.85; 0.66 | 0.55 |
| SECONDARY Change From Baseline in Patient Systolic Blood Pressure at 12 Months |
2.69; -3.05 | 0.03 sig |
| SECONDARY Change From Baseline in Patient Diabetes Distress at 6 Months |
-2.68; -2.40 | 0.76 |
| SECONDARY Change From Baseline in Patient Diabetes Distress at 12 Months |
-2.67; -2.34 | 0.72 |
| SECONDARY Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating |
0.14; 0.37 | 0.38 |
| SECONDARY Change in Diabetes Self-care Behaviors in Patient: Physical Activity |
0.22; 0.56 | 0.45 |
| SECONDARY Change in Diabetes Self-care Behaviors in Patient: Medication Adherence |
0.01; 0.27; 0.04; 0.05; -0.02; 0.39 | 0.40 |
| SECONDARY Change in Self-efficacy of Patient |
0.09; 0.59 | 0.06 |
| SECONDARY Change in Patient Activation in Patient |
3.18; 3.54 | 0.92 |
| SECONDARY Patient Perceived Overall Satisfaction With SP Support for Diabetes |
0.38; -0.37 | 0.11 |
| SECONDARY Patient Perception of SP Support: Supportive and Non-supportive Behaviors |
0.22; 0.04 | 0.34 |
| SECONDARY Impact of COVID on Ability to Manage Diabetes |
6; 4; 53; 64; 2; 1 | — |
| SECONDARY Change in Diabetes Distress in Support Person |
0.45; -0.74 | 0.49 |
| SECONDARY Change in Self-efficacy of Support Person |
0.07; -0.72 | 0.08 |
Eligibility Criteria
Patient Inclusion Criteria:
- Have a diagnosis of Type 2 diabetes
- Most recent HbA1c done in the 3 months prior to screening phone call >= 7.5%
- Plan to use recruiting site for health care over the next 12 months after enrollment
- Must be able to identify a family member or friend who is willing to be involved in their health care
Patient Exclusion Criteria:
- Diagnosis (active or prior) of Alzheimer's disease or dementia
- Preferred language is not English or Spanish
- Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date
- Diagnosis of gestational diabetes without any other diabetes diagnoses
- Diagnosed with diabetes at age < 21 years
- Pregnant or planning to become pregnant in the next 12 months
- Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
- Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
Support Person Inclusion Criteria:
- Able to attend intervention sessions in person or remotely via online video-conferencing
- At least 21 years old
Support Person Exclusion Criteria:
- Does not speak English or Spanish
- Receives pay for caring for the patient
- Has self-reported serious mental illness (schizophrenia)
- Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
- Has significant cognitive impairment (Alzheimer's disease or dementia)
- Lives in a nursing home or long-term care facility
- Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Data sourced from ClinicalTrials.gov (NCT03812614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.