DiabetesSTIC2IT-2NCT06569290
Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
A study testing Primer postcard, Behavioral theory-informed recruitment letter (prospect theory) and 2 phone calls in people with Diabetes and Pharmacist-Patient Relations, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Pharmacist-Patient Relations, Medication Adherence
- What is being tested?
- Primer postcard, Behavioral theory-informed recruitment letter (prospect theory) and 2 phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- English or Spanish speaking
- Receiving care from a BMC primary care provider
- Non-adherent to prescribed oral glucose-lowering medications as per pharmacy dispense records (proportion of days covered <80% to at least one eligible medication in last 6 months)
- Evidence of poor or worsening disease control
Who cannot join
- Evidence of terminal conditions
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.
Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms.
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.
- Conditions
- Diabetes, Pharmacist-Patient Relations, Medication Adherence
- Being tested
- Primer postcard, Control recruitment letter, Behavioral theory-informed recruitment letter (prospect theory), 2 phone calls, 4 phone calls
- Medical subject headings
- Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primer postcardBehavioural
Inclusion of a mailed primer post card
Control recruitment letterBehavioural
a recruitment letter without any behaviorally-informed language
Behavioral theory-informed recruitment letter (prospect theory)Behavioural
the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message.
2 phone callsBehavioural
2 recruitment phone calls made by the call center
4 phone callsBehavioural
4 recruitment phone calls made by the call center
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Post card; control letter; 2 calls Receives: Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 2 phone calls |
| Arm 2 | Active comparator | Post card; control letter; 4 calls Receives: Behavioral: Primer postcard; Behavioral: Control recruitment letter; Behavioral: 4 phone calls |
| Arm 3 | Active comparator | Post card; behavioral letter; 2 calls Receives: Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 2 phone calls |
| Arm 4 | Active comparator | Post card; behavioral letter; 4 calls Receives: Behavioral: Primer postcard; Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 4 phone calls |
| Arm 5 | Active comparator | No post card; control letter; 2 calls Receives: Behavioral: Control recruitment letter; Behavioral: 2 phone calls |
| Arm 6 | Active comparator | No post card; control letter; 4 calls Receives: Behavioral: Control recruitment letter; Behavioral: 4 phone calls |
| Arm 7 | Active comparator | No post card; behavioral letter; 2 calls Receives: Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 2 phone calls |
| Arm 8 | Active comparator | No post card; behavioral letter; 4 calls Receives: Behavioral: Behavioral theory-informed recruitment letter (prospect theory); Behavioral: 4 phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of a clinical pharmacist adherence counseling appointment
rate of participants who completed their clinical pharmacist consultation
Measured: within 8 weeks of receiving the intervention
Secondary outcomes (4)
Schedule rates for clinical pharmacist adherence counseling appointment
rate of participants who scheduled an appointment
Measured: within 8 weeks of receiving the intervention
No-show/cancellation rates
rate of participants who did not show up to their appointment or cancelled their appointment after scheduling it
Measured: within 8 weeks of receiving the intervention
Glucose-lowering medication adherence
proportion of days covered of a glucose-lowering medication
Measured: 3 months after randomization
Clinical outcome - HbA1c
HbA1c levels using EHR data
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start3 Mar 2025
- Primary completion12 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Boston Medical Center, Columbia University
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
- Investigators
- Julie C Lauffenburger, PharmD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569290
- Sponsor's protocol ID
- 2024P002222
- Other IDs
- 5P30AG064199-05
- Acronym
- STIC2IT-2
- Status last verified
- Jul 2026
- First submitted
- 22 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Testing of Recruitment Methodology for Behavioral Medication Adherence Interventions Using Behavioral Science-based Approaches
- ClinicalTrials.gov ID
- NCT06569290
- Acronym / sponsor ID
- STIC2IT-2 / 2024P002222
- Conditions
- Diabetes, Pharmacist-Patient Relations, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Boston Medical Center, Columbia University
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the proposed research is to prepare the clinical pharmacist intervention for sustainable implementation and dissemination. Because the effectiveness of the intervention has already been demonstrated in a NIH Stage Model IV trial, the investigators propose an Effectiveness-Implementation Type 3 Hybrid design, in which the primary focus is on testing different implementation methods, while secondarily observing clinical effects. The investigators' overarching hypothesis is to identify the most impactful elements of a behavioral theory-informed recruitment approach, which can be replicable across clinical settings.
Accordingly, the investigators propose to perform testing of a behaviorally-informed recruitment approaches in a community-based setting. Like the previous Tele-Pharmacy Intervention to Improve Treatment Adherence (STIC2IT) trial (NCT02512276), participants will be English or Spanish speaking adults ≥18 years of age identified through the electronic health record (EHR) as having poor disease control and/or poor medication adherence for diabetes. The primary care physicians of eligible patients identified through the EHR will be contacted to opt-out any patients they wish not to be included. Patients will then be randomized to each of the following conditions, such that there will be 8 total arms: (1) inclusion of a mailer primer (yes/no), (2) the most successful recruitment letter from the preliminary study using prospect theory (versus the control letter), and (3) intensity of the intervention outreach (4 calls vs. 2 calls). The investigators plan to enroll 584 participants who meet the inclusion criteria, with 73 patients per each of the 8 study arms.
Patients across all arms who agree to be scheduled will receive an appointment with one of the clinical pharmacists within the established BMC pharmacist program. The primary outcome will be completion of a clinical pharmacist appointment within 8 weeks after randomization. Key secondary outcomes will include scheduled visit rates, no-show rates for scheduled appointments, medication adherence over the 3-month follow-up, and clinical outcomes, including HbA1c levels measured using EHR data in the 3 months after randomization. The medication adherence and clinical outcomes will be used for the Aim 2 evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Primer postcard, Behavioral: Control recruitment letter, Behavioral: 2 phone callsPost card; control letter; 2 calls |
| Arm 2 | Active comparator | Behavioral: Primer postcard, Behavioral: Control recruitment letter, Behavioral: 4 phone callsPost card; control letter; 4 calls |
| Arm 3 | Active comparator | Behavioral: Primer postcard, Behavioral: Behavioral theory-informed recruitment letter (prospect theory), Behavioral: 2 phone callsPost card; behavioral letter; 2 calls |
| Arm 4 | Active comparator | Behavioral: Primer postcard, Behavioral: Behavioral theory-informed recruitment letter (prospect theory), Behavioral: 4 phone callsPost card; behavioral letter; 4 calls |
| Arm 5 | Active comparator | Behavioral: Control recruitment letter, Behavioral: 2 phone callsNo post card; control letter; 2 calls |
| Arm 6 | Active comparator | Behavioral: Control recruitment letter, Behavioral: 4 phone callsNo post card; control letter; 4 calls |
| Arm 7 | Active comparator | Behavioral: Behavioral theory-informed recruitment letter (prospect theory), Behavioral: 2 phone callsNo post card; behavioral letter; 2 calls |
| Arm 8 | Active comparator | Behavioral: Behavioral theory-informed recruitment letter (prospect theory), Behavioral: 4 phone callsNo post card; behavioral letter; 4 calls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age
- English or Spanish speaking
- Receiving care from a BMC primary care provider
- Non-adherent to prescribed oral glucose-lowering medications as per pharmacy dispense records (proportion of days covered <80% to at least one eligible medication in last 6 months)
- Evidence of poor or worsening disease control
Key exclusion criteria (1 listed)
- Evidence of terminal conditions
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 |
|---|---|---|
| Primer postcardInclusion of a mailed primer post card | Behavioural | Arm 1, Arm 2, Arm 3, Arm 4 |
| Control recruitment lettera recruitment letter without any behaviorally-informed language | Behavioural | Arm 1, Arm 2, Arm 5, Arm 6 |
| Behavioral theory-informed recruitment letter (prospect theory)the recruitment letter will use prospect theory and deliver a low risk, gain-framed behaviorally-informed message. | Behavioural | Arm 3, Arm 4, Arm 7, Arm 8 |
| 2 phone calls2 recruitment phone calls made by the call center | Behavioural | Arm 1, Arm 3, Arm 5, Arm 7 |
| 4 phone calls4 recruitment phone calls made by the call center | Behavioural | Arm 2, Arm 4, Arm 6, Arm 8 |
Primary outcome
Completion of a clinical pharmacist adherence counseling appointment
Time frame: within 8 weeks of receiving the intervention
rate of participants who completed their clinical pharmacist consultation
4 secondary outcomes
Schedule rates for clinical pharmacist adherence counseling appointment
Time frame: within 8 weeks of receiving the intervention
No-show/cancellation rates
Time frame: within 8 weeks of receiving the intervention
Glucose-lowering medication adherence
Time frame: 3 months after randomization
Clinical outcome - HbA1c
Time frame: 3 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Julie C Lauffenburger, PharmD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primer postcard, Behavioral theory-informed recruitment letter (prospect theory) and 2 phone calls in people with Diabetes and Pharmacist-Patient Relations, run by Brigham and Women's Hospital at 1 site 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 5 inclusion and 1 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Completion of a clinical pharmacist adherence counseling appointment (time frame: within 8 weeks of receiving the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.