Adults 21 to 75, any sex, with Diabetes Mellitus or High Blood Pressure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Patient Glycemic Control at 6 MonthsPrimary· Baseline vs. 6 months
Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fi
Group
Value
95% CI
FAM-ACT
-0.43
-0.85 – -0.00
I-DSMES
-0.97
-1.38 – -0.55
Change From Baseline in Patient Glycemic Control at 12 MonthsSecondary· Baseline vs. 12 months
Hemoglobin A1c (HbA1c, percent) was measured through finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
Group
Value
95% CI
FAM-ACT
-0.67
-1.14 – -0.20
I-DSMES
-0.65
-1.11 – -0.19
Change From Baseline in Patient Systolic Blood Pressure at 6 MonthsSecondary· Baseline vs. 6 months
SBP was measured using an electronic, upper arm blood pressure monitor.
Group
Value
95% CI
FAM-ACT
-0.85
-4.33 – 2.63
I-DSMES
0.66
-2.78 – 4.10
Change From Baseline in Patient Systolic Blood Pressure at 12 MonthsSecondary· Baseline vs. 12 months
SBP was measured using an electronic, upper arm blood pressure monitor.
Group
Value
95% CI
FAM-ACT
2.69
-0.98 – 6.35
I-DSMES
-3.05
-6.70 – 0.59
Change From Baseline in Patient Diabetes Distress at 6 MonthsSecondary· Baseline vs. 6 months
Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Group
Value
95% CI
FAM-ACT
-2.68
-4.01 – -1.35
I-DSMES
-2.40
-3.71 – -1.09
Change From Baseline in Patient Diabetes Distress at 12 MonthsSecondary· Baseline vs. 12 months
Patient diabetes distress was assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items were summed to create a total score with a range of 0 to 20. A total score of \>=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
Group
Value
95% CI
FAM-ACT
-2.67
-3.94 – -1.39
I-DSMES
-2.34
-3.59 – -1.10
Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy EatingSecondary· Baseline vs. 6 months
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.
Group
Value
95% CI
FAM-ACT
0.14
-0.24 – 0.51
I-DSMES
0.37
-0.00 – 0.74
Change in Diabetes Self-care Behaviors in Patient: Physical ActivitySecondary· Baseline vs. 6 months
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence.
Group
Value
95% CI
FAM-ACT
0.52
-0.14 – 1.17
I-DSMES
0.70
0.05 – 1.35
Change in Diabetes Self-care Behaviors in Patient: Medication AdherenceSecondary· Baseline vs. 6 months
The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Results were scored separately within each domain. Scores range from 1 to 7, representing the number of days per week the patient engages in the behavior. Higher numbers indicate better adherence. Three types of medication adherence were assessed: number of days diabetes medications (non-insulin) were taken; number of days blood pressure medications were taken; number of days cholesterol medications were taken. Note
Diabetes medication
Group
Value
95% CI
FAM-ACT
0.12
-0.34 – 0.58
I-DSMES
0.01
-0.43 – 0.45
Blood pressure medication
Group
Value
95% CI
FAM-ACT
0.05
-0.56 – 0.66
I-DSMES
0.09
-0.64 – 0.81
Cholesterol medication
Group
Value
95% CI
FAM-ACT
0.01
-0.69 – 71
I-DSMES
0.44
-0.32 – 1.20
Change in Self-efficacy of PatientSecondary· Baseline vs. 6 months
Patient self-efficacy for managing diabetes was assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management (0, not at all confident to 10, very confident). Item responses are averaged, with mean scores ranging from 0 to 10. Higher numbers indicate greater self-efficacy.
Group
Value
95% CI
FAM-ACT
0.33
-0.05 – 0.71
I-DSMES
0.34
-0.03 – 0.72
Change in Patient Activation in PatientSecondary· Baseline vs. 6 months
Patient activation was assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation. Item scale locations were transformed from the original logit metric to a user-friendly 0-100 metric where 0=the lowest possible activation and 100=the highest possible activation as measured by this set
Group
Value
95% CI
FAM-ACT
5.95
1.08 – 10.82
I-DSMES
3.02
-1.79 – 7.84
Patient Perceived Overall Satisfaction With SP Support for DiabetesSecondary· Baseline vs. 6 months
Patient satisfaction with support person (SP) support for diabetes was assessed with 2\* items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses were rated on a 7-point scale ranging from 1, "strongly disagree" to 7 "strongly agree". Responses are summed to create a total score with a range of 2 to 14. Higher numbers indicate greater satisfaction.
Group
Value
95% CI
FAM-ACT
0.38
-0.29 – 1.04
I-DSMES
-0.37
-1.03 – 0.28
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected over 1 year, beginning at the time of randomization and ending after the 12-month study assessment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 13 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03812614.