N/A N=478 Randomized Single-blind Treatment

Caring Others Increasing EngageMent in PACT

Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT02328326 ↗

Enrolled (actual)

478

Serious AEs

6.5%

Results posted

Jul 2020

Primary outcome: Primary: Change in Patient Activation, as Measured by Patient Activation Measure - 13 — 2.94; 1.78 units on a scale — p=0.048

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CO-IMPACT (Other); PACT (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient Activation, as Measured by Patient Activation Measure - 13	2.94; 1.78	0.048 sig
PRIMARY Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine	0.14; -0.73	0.32
SECONDARY Change in Diabetes Self-Management Behavior - Healthy Eating	1.12; 0.50	0.01 sig
SECONDARY Change in Glycemic Control	-0.05; -0.28	0.33
SECONDARY Change in Systolic Blood Pressure	-6.41; -2.46	0.18
SECONDARY Change in Diabetes Distress	-0.25; -0.62	0.83
SECONDARY Change in Activation in Health Encounters	0.23; 0.33	0.79
SECONDARY Change in Non-Fasting Lipid Levels	-0.11; -0.21	0.21
SECONDARY Change in Patient Satisfaction With Healthcare System Support for Family Supporter	35; 20; 80; 91	—
SECONDARY Change in Supporter Use of Autonomy-Supportive Communication	0.27; 0.05	0.01 sig
SECONDARY Change in Smoking Status	2; 3; 1; 5; 112; 105	0.17
SECONDARY Change in Diabetes Self-Management Behavior - Physical Activity	0.09; 0.46	0.87
SECONDARY Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing	0.17; 0.19	0.31
SECONDARY Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing	0.51; 0.48	0.87
SECONDARY Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed	0.14; 0.23	0.56
SECONDARY Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed	0.14; 0.48	0.67
SECONDARY Change in Diabetes Self-Management Behavior - Check Feet	0.72; 0.72	0.29

Summary

This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.

Eligibility Criteria

Inclusion Criteria

Patient Inclusion Criteria:

Provide signed and dated informed consent form
Plan to be be available for the duration of the study
Male or female, age 30-70 years old
Plan to get most diabetes care at recruiting VA primary care clinic over the subsequent 12 months
Able to use telephone to respond to bi-weekly automated Interactive Voice Response (IVR) calls
Be able to identify an adult family member or friend who is regularly involved in their health management or health care (involved with medications, managing sugars, coming to appointments, etc)
Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2 outpatient encounters (OR a diabetes medication (at least one >3 month prescription from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an assigned VAprimary care provider and at least 2 visits to VA primary care in the previous 12 months, (3) poor glycemic control (last HbA1C within 9 months >8%) OR poor blood pressure control (last BP 160/100 or mean 6 month BP >150/90)

Care Partner Inclusion Criteria:

21 years old or older
Fluent in English
Live in the United States

Exclusion Criteria

Patient Exclusion Criteria:

Expect to have >1 month gap in VA care in the 12 months following enrollment (e.g. snowbird travel).
Plan to receive the majority of their care for diabetes mainly from a non-Primary Care provider in the 12 months following enrollment
Have a VA resident/trainee as their main primary care provider
Live in a nursing home OR assisted living
Have significant cognitive impairment as measured by an Electronic Medical Record (EMR) diagnosis of Alzheimer's disease or dementia, or a score of <4 on the Callahan screener to identify cognitive impairment
Need help with more than two basic activities of daily living (ADLs) as measured by the Katz Basic Activities of Daily Living Scale
Do not speak English
Have a life-limiting severe illness (such as stage renal disease [ESRD] requiring dialysis, chronic obstructive pulmonary disease (COPD) requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
Are concurrently enrolled in another research study or clinical program, at time of enrollment, that could conflict with the current study's protocol (e.g. another diabetes management research intervention, or VA tele-buddy program involving frequent phone calls)
Do not have a working phone or are not able to use a telephone to respond to automated IVR calls
Currently Pregnant or planning to become pregnant at time of enrollment
Have a serious mental illness or active substance abuse issue

Care Partner Exclusion Criteria:

Receive pay for caring for the patient
talks with patient about health less than two times per month
Have significant cognitive impairment as measured by a score of 4 or less <4 on the Callahan screener to identify cognitive impairment
Need help with more than two basic ADL as measured by the Katz Basic Activities of Daily Living Scale
Have a life-limiting severe illness (such as end-stage renal disease requiring dialysis, chronic lung disease requiring oxygen, cancer undergoing active treatment, receiving palliative/hospice care)
Ever told by a doctor they have dementia, schizophrenia, or manic depression

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02328326). 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.