Shared Health Appointments and Reciprocal Enhanced Support
NCT ID: NCT02132676
Last Updated: 2020-09-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1536 participants
OBSERVATIONAL
2016-04-25
2019-07-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Home-Based Health Messaging for Patients With Hypertension and Diabetes
NCT00119054
Improving Diabetes Care Via Telephone Assessment and Patient Education
NCT00012649
Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
NCT02522494
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions
NCT02953262
Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
NCT05169359
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered.
No interventions assigned to this group
Usual Care
The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA).
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Veteran receiving care at a participating VA Medical Center
* Meets at least one of the following criteria in the past 2 years;
* at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
* at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
* At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies
* Poor glycemic control, indicated by a HbA1c in the past 6 months or:
* at least 7.5% if age \<70, or
* at least 8% if age 70+
* Has a current address and telephone number listed in VA databases
* Is competent to provide informed consent
* Can communicate in English and by telephone
* Able to participate in an outpatient program
Exclusion Criteria
* Active substance abuse disorder (smoking cigarettes is not an exclusion)
* Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
* Terminally ill
* Prisoner
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mary Ellen M Heisler, MD MPA
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Jeffery SM, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. Trials. 2017 May 26;18(1):239. doi: 10.1186/s13063-017-1959-7.
Kowalski CP, Veeser M, Heisler M. Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption. BMC Fam Pract. 2018 Jul 7;19(1):109. doi: 10.1186/s12875-018-0797-3.
Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2021 Jun;36(6):1648-1655. doi: 10.1007/s11606-020-06570-y. Epub 2021 Feb 2.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIR 15-321
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.