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Caring Others Increasing EngageMent in PACT (CO-IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328326
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : July 13, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Other: CO-IMPACT Other: PACT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
Actual Study Start Date : November 16, 2016
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : August 21, 2020

Arm Intervention/treatment
Experimental: CO-IMPACT
patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns
Other: CO-IMPACT
Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter

Active Comparator: PACT
patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Other: PACT
participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits




Primary Outcome Measures :
  1. Change in Patient Activation, as Measured by Patient Activation Measure - 13 [ Time Frame: baseline to 12 months ]
    (Patient Activation Measure-13) - theoretical range of potential values (0,100), higher scores mean a better outcome, mean is computed for the difference in PAM scores from baseline to twelve months (PAM at 12mo minus PAM at Baseline), among patient participants

  2. Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine [ Time Frame: Baseline to 12 months ]
    UKPDS Risk Engine, among patient participants only, theoretical range is 0 to 100, lower score equals a better outcome. Mean is computed on the difference in scores for baseline to 12 months (12mo UKPDS score minus Baseline UKPDS score).


Secondary Outcome Measures :
  1. Diabetes Self-management Behavior [ Time Frame: 12 months ]
    Summary of Diabetes Self-Care Activities, among patient participants

  2. Glycemic Control [ Time Frame: 12 months ]
    Hemoglobin A1c, among patient participants

  3. Systolic Blood Pressure Control [ Time Frame: 12 months ]
    average of two SBP readings, among patient participants

  4. Diabetes Distress [ Time Frame: 12 months ]
    PAID Problem Areas in Diabetes Scale, among patient participants

  5. Activation in Health Encounters [ Time Frame: 12 months ]
    PEPPI-5 Perceived Efficacy in Patient-Physician Interactions, among patient participants

  6. Non-fasting Lipid Levels [ Time Frame: 12 months ]
    Non-HDL Cholesterol, among patient participants

  7. Patient Satisfaction With Diabetes Social Support [ Time Frame: 12 months ]
    Diabetes Care Profile - Support Subscale, among patient participants

  8. Supporter Use of Autonomy-supportive Communication [ Time Frame: 12 months ]
    Important Other Climate Questionnaire, among patient participants

  9. Smoking Status [ Time Frame: 12 months ]
    among patient participants

  10. Medication Adherence [ Time Frame: 12 months ]
    diabetes/hypertension/cholesterol medication adherence among patient participants


Other Outcome Measures:
  1. Supporter Self-Efficacy for Helping With Diabetes Care [ Time Frame: 12 months ]
    Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants

  2. Caregiver Burden [ Time Frame: 12 months ]
    Caregiver Strain Index, among family supporter participants

  3. Supporter Distress About Patient Participant's Diabetes [ Time Frame: 12 months ]
    Adapted Problem Areas In Diabetes Scale, among family supporter participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328326


Locations
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United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ann-Marie Rosland, MD MS VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Publications of Results:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02328326    
Other Study ID Numbers: IIR 14-074
First Posted: December 31, 2014    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Diabetes
diabetes self-management
patient activation
social support
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases