Caring Others Increasing EngageMent in PACT

NCT02328326 | Completed Results

• 1 other identifier: IIR 14-074
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

Diabetes; diabetes self-management; patient activation; social support

Outcome Measures

Primary Outcomes (2)

• Change in Patient Activation, as Measured by Patient Activation Measure - 13

  Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants

  Baseline to 12 months

• Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine

  UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.

  Baseline to 12 months

Secondary Outcomes (15)

• Change in Diabetes Self-Management Behavior - Healthy Eating

  Baseline to 12 months

• Change in Glycemic Control

  Baseline to 12 months

• Change in Systolic Blood Pressure

  Baseline to 12 months

• Change in Diabetes Distress

  Baseline to 12 months

• Change in Activation in Health Encounters

  Baseline to 12 months

Other Outcomes (4)

• Change in Diabetes Self-Efficacy

  Baseline to 12 months

• Change in Supporter Self-Efficacy for Helping With Diabetes Care

  Baseline to 12 months

• Change in Caregiver Burden

  Baseline to 12 months

Study Arms (2)

CO-IMPACT

EXPERIMENTAL

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

PACT

ACTIVE COMPARATOR

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

Interventions

CO-IMPACT OTHER

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

CO-IMPACT

PACT OTHER

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

PACT

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years old or older
• Fluent in English
• Live in the United States

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (3)

• Rosland AM, Piette JD, Trivedi R, Kerr EA, Stoll S, Tremblay A, Heisler M. Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial. Trials. 2018 Jul 24;19(1):394. doi: 10.1186/s13063-018-2785-2.

  PMID: 30041685 BACKGROUND

• Zupa MF, Lee A, Piette JD, Trivedi R, Youk A, Heisler M, Rosland AM. Impact of a Dyadic Intervention on Family Supporter Involvement in Helping Adults Manage Type 2 Diabetes. J Gen Intern Med. 2022 Mar;37(4):761-768. doi: 10.1007/s11606-021-06946-8. Epub 2021 Jul 8.

  PMID: 34240285 RESULT

• Rosland AM, Piette JD, Trivedi R, Lee A, Stoll S, Youk AO, Obrosky DS, Deverts D, Kerr EA, Heisler M. Effectiveness of a Health Coaching Intervention for Patient-Family Dyads to Improve Outcomes Among Adults With Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2237960. doi: 10.1001/jamanetworkopen.2022.37960.

  PMID: 36374502 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Patient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Ann-Marie Rosland
• Organization: VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion

Ann-Marie.rosland@va.gov

4123602259

Study Officials

• Ann-Marie Rosland, MD MS

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 31, 2014
• Study Start: November 16, 2016
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2020
• Last Updated: October 6, 2021
• Results First Posted: July 13, 2020

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Members of the scientific community should contact the PI. De-identified data may only be provided after requestors and data providers sign a standard federal agency Data Use Agreement.

Locations

US (2)