DiabetesCO-IMPACTNCT02328326
Caring Others Increasing EngageMent in PACT
A study testing CO-IMPACT and PACT in people with Diabetes, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- CO-IMPACT and PACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Nov 2016to 6 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
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.
Read the detailed description
Background:
Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.
Objectives:
The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.
The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.
Methods:
This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.
The intervention provides patient-supporter dyads: 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. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters.
Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.
- Conditions
- Diabetes
- Being tested
- CO-IMPACT, PACT
- Keywords
- Diabetes, diabetes self-management, patient activation, social support
- Medical subject headings
- Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-IMPACTOther
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
PACTOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: PACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline to 12 months
Secondary outcomes (15)
Change in Diabetes Self-Management Behavior - Healthy Eating
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Glycemic Control
Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Systolic Blood Pressure
mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Distress
Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Activation in Health Encounters
Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Non-Fasting Lipid Levels
Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Patient Satisfaction With Healthcare System Support for Family Supporter
Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.
Measured: Baseline to 12 months
Change in Supporter Use of Autonomy-Supportive Communication
Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Smoking Status
Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Physical Activity
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Check Feet
Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study start16 Nov 2016
- Primary completion6 Jun 2019
- Study completion6 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann-Marie Rosland, MD MS, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328326
- Sponsor's protocol ID
- IIR 14-074
- Acronym
- CO-IMPACT
- Status last verified
- Sep 2021
- First submitted
- 10 Dec 2014
- Last updated
- 6 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final dataset underlying publication resulting from this research will be shared upon request. Members of the scientific community can request a de-identified copy of the final dataset (i.e., dataset underlying any publication).
Publications
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.
PubMed 30041685Zupa 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.
PubMed 34240285Rosland 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.
PubMed 36374502
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management
- ClinicalTrials.gov ID
- NCT02328326
- Acronym / sponsor ID
- CO-IMPACT / IIR 14-074
- Conditions
- Diabetes
- Keywords
- Diabetes, diabetes self-management, patient activation, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2020 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources.
Objectives:
The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans.
The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks.
Methods:
This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months.
The intervention provides patient-supporter dyads: 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. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters.
Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO-IMPACT | Experimental | Other: CO-IMPACTpatient 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 |
| PACT | Active comparator | Other: PACTpatient 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 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-IMPACTPrimary 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 | Other | CO-IMPACT |
| PACTparticipants 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 |
Primary outcome
Change in Patient Activation, as Measured by Patient Activation Measure - 13
Time frame: Baseline to 12 months
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
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, 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.
15 secondary outcomes
Change in Diabetes Self-Management Behavior - Healthy Eating
Time frame: Baseline to 12 months
Change in Glycemic Control
Time frame: Baseline to 12 months
Change in Systolic Blood Pressure
Time frame: Baseline to 12 months
Change in Diabetes Distress
Time frame: Baseline to 12 months
Change in Activation in Health Encounters
Time frame: Baseline to 12 months
Change in Non-Fasting Lipid Levels
Time frame: Baseline to 12 months
Change in Patient Satisfaction With Healthcare System Support for Family Supporter
Time frame: Baseline to 12 months
Change in Supporter Use of Autonomy-Supportive Communication
Time frame: Baseline to 12 months
Change in Smoking Status
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Physical Activity
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed
Time frame: Baseline to 12 months
Change in Diabetes Self-Management Behavior - Check Feet
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30041685Rosland 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.
- Results publication: PubMed 34240285Zupa 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.
- Derived from this study: PubMed 36374502Rosland 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.
- Individual participant dataSharing planned: Yes. Final dataset underlying publication resulting from this research will be shared upon request. Members of the scientific community can request a de-identified copy of the final dataset (i.e., dataset underlying any publication).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Marie Rosland, MD MS principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-IMPACT and PACT in people with Diabetes, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Activation, as Measured by Patient Activation Measure - 13 (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.