Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support



Status:Not yet recruiting
Conditions:High Blood Pressure (Hypertension), Diabetes, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:30 - 70
Updated:1/25/2019
Start Date:July 2019
End Date:January 2024
Contact:Ann-Marie R Rosland, MD, MS
Email:roslandam@pitt.edu
Phone:412-692-4889

Use our guide to learn which trials are right for you!

Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications

The objective of this study is to compare the effectiveness of a novel program—Family
Partners for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management
education and care management(I-DSME/CM).

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes
management:

1. provide family members core behavioral strategies, hands-on training, and tools directed
at specific roles in supporting diabetes management (e.g. how to support action planning
and medication adherence)

2. teach family members how to deliver support in ways that will empower patients and not
sabotage support efforts (e.g. empathetic and autonomy supportive communication)

3. teach family supporters ways to boost patient engagement in healthcare (e.g. how to
support healthcare visit preparation and participatory communication with providers)

CHWs will deliver FAM-ACT through family-focused group DSME sessions plus family-focused care
management sessions to patient-family supporter dyads at an urban federally qualified health
center. 244 patients with type 2 diabetes, and either poor glycemic or blood pressure
control, will be randomized together with a family supporter, to receive either FAM-ACT or
more traditional CHW-led individually-focused DSME/CM over 12 months.

Patient Inclusion Criteria:

1. age between 30 and 70 years old

2. actively receiving primary care at CHASS Inc health center

3. fluent in English or Spanish

4. diagnosis of diabetes from two outpatient encounters at CHASS

5. Most recent HbA1c (past 3 months) ≥8.0%

OR poor blood pressure control [poor blood pressure control is defined as:

(If they have >1 BP in last 6 months) Most recent SBP>=150 and mean SBP over 9 months
>=150 (If only 1 BP in last 6 months) Last SBP in last 6 months >=160 and no other BP
measures AND exclude from poor BP group if last BP diastolic or mean diastolic is
<=65]

6. able to identify a family member or friend who meets the family supporter
inclusion/exclusion criteria below and is willing to participate in the study

Patient Exclusion Criteria:

1. diagnosed with diabetes at age <21 years

2. have significant cognitive impairment,

3. need help with basic activities of daily living

4. live in a nursing home

5. are not able to be contacted by phone,

6. are pregnant or planning to become pregnant during the course of the study

7. have self-reported serious mental illness or active substance abuse, or

8. have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease
requiring oxygen).

Family Supporter Inclusion Criteria:

1. Family members or friends can live with or apart from the patient participant

2. At least 21 years old

Family Supporter Exclusion Criteria:

1. receive pay for caring for the patient

2. do not speak English or Spanish

3. are not able to be contacted by phone

4. have self-reported serious mental illness or active substance abuse

5. need help with basic activities of daily living, or

6. have a life-limiting severe illness.
We found this trial at
2
sites
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-586-9782
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Detroit, Michigan 48209
Principal Investigator: Michelle Heisler, MD MPH
Phone: 313-849-3920
?
mi
from
Detroit, MI
Click here to add this to my saved trials