DiabetesNCT02411006
Effect of Reminders on Adherence
A study testing Prediction mailing, Commitment mailing and Reminder in people with Diabetes and Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Prediction mailing, Commitment mailing and Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,088 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jun 2015
- 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
- customers of the investigators' insurance company partner
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Prediction and Pre-commitment Mailings for Medication Adherence
The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence.
Read the detailed description
The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence. The investigators will send mailings to subjects once per month, and elicit responses via mail, phone, and web surveys.
- Conditions
- Diabetes, Hypertension
- Being tested
- Prediction mailing, Commitment mailing, Reminder, Anonymity, Identification
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction mailingBehavioural
Ask people to predict their upcoming medication adherence
Commitment mailingBehavioural
Ask people to commit to their upcoming medication adherence
ReminderBehavioural
Remind people to take their medicine
AnonymityBehavioural
Keep patient predictions and commitment anonymous
IdentificationBehavioural
Ask patients to report their predictions and commitments
| Study group | Role | What they receive |
|---|---|---|
| Usual care control | No intervention | No intervention, just usual care from the insurance company |
| Reminder control | Experimental | Send a reminder to subjects every month Receives: Behavioral: Reminder |
| Anonymous prediction | Experimental | Ask subjects to anonymously predict their upcoming medication adherence Receives: Behavioral: Prediction mailing; Behavioral: Reminder; Behavioral: Anonymity |
| Anonymous commitment | Experimental | Ask subjects to anonymously commit to their upcoming medication adherence Receives: Behavioral: Commitment mailing; Behavioral: Reminder; Behavioral: Anonymity |
| Identified prediction | Experimental | Ask subjects to predict their upcoming medication adherence and report it Receives: Behavioral: Prediction mailing; Behavioral: Reminder; Behavioral: Identification |
| Identified commitment | Experimental | Ask subjects to commit to their upcoming medication adherence and report it Receives: Behavioral: Commitment mailing; Behavioral: Reminder; Behavioral: Identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication refills
frequency of refilling medication
Measured: 6 months
Secondary outcomes (2)
Hemoglobin A1C
Measured: 6 months
LDL cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 47,088 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Milkman, Ph.D, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411006
- Sponsor's protocol ID
- H14P001
- Status last verified
- Sep 2016
- First submitted
- 3 Apr 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
Publications
Dai H, Mao D, Volpp KG, Pearce HE, Relish MJ, Lawnicki VF, Milkman KL. The effect of interactive reminders on medication adherence: A randomized trial. Prev Med. 2017 Oct;103:98-102. doi: 10.1016/j.ypmed.2017.07.019. Epub 2017 Jul 24.
PubMed 28751176
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Pre-commitment Mailings for Medication Adherence
- ClinicalTrials.gov ID
- NCT02411006
- Acronym / sponsor ID
- H14P001
- Conditions
- Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,088 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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 investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence.
Detailed description
The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence. The investigators will send mailings to subjects once per month, and elicit responses via mail, phone, and web surveys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Usual care control | No intervention | –No intervention, just usual care from the insurance company |
| Reminder control | Experimental | Behavioral: ReminderSend a reminder to subjects every month |
| Anonymous prediction | Experimental | Behavioral: Prediction mailing, Behavioral: Reminder, Behavioral: AnonymityAsk subjects to anonymously predict their upcoming medication adherence |
| Anonymous commitment | Experimental | Behavioral: Commitment mailing, Behavioral: Reminder, Behavioral: AnonymityAsk subjects to anonymously commit to their upcoming medication adherence |
| Identified prediction | Experimental | Behavioral: Prediction mailing, Behavioral: Reminder, Behavioral: IdentificationAsk subjects to predict their upcoming medication adherence and report it |
| Identified commitment | Experimental | Behavioral: Commitment mailing, Behavioral: Reminder, Behavioral: IdentificationAsk subjects to commit to their upcoming medication adherence and report it |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- customers of the investigators' insurance company partner
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Prediction mailingAsk people to predict their upcoming medication adherence | Behavioural | Anonymous prediction, Identified prediction |
| Commitment mailingAsk people to commit to their upcoming medication adherence | Behavioural | Anonymous commitment, Identified commitment |
| ReminderRemind people to take their medicine | Behavioural | Anonymous commitment, Anonymous prediction, Identified commitment, Identified prediction, Reminder control |
| AnonymityKeep patient predictions and commitment anonymous | Behavioural | Anonymous commitment, Anonymous prediction |
| IdentificationAsk patients to report their predictions and commitments | Behavioural | Identified commitment, Identified prediction |
Primary outcome
Medication refills
Time frame: 6 months
frequency of refilling medication
2 secondary outcomes
Hemoglobin A1C
Time frame: 6 months
LDL cholesterol
Time frame: 6 months
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 27 Sep 2016.
- Derived from this study: PubMed 28751176Dai H, Mao D, Volpp KG, Pearce HE, Relish MJ, Lawnicki VF, Milkman KL. The effect of interactive reminders on medication adherence: A randomized trial. Prev Med. 2017 Oct;103:98-102. doi: 10.1016/j.ypmed.2017.07.019. Epub 2017 Jul 24.
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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.
Katherine Milkman, Ph.D principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prediction mailing, Commitment mailing and Reminder in people with Diabetes and Hypertension, run by University of Pennsylvania 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 1 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 27 Sep 2016. 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?
Medication refills (time frame: 6 months). 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 NCT02411006, which also lists 1 linked publication.
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 27 Sep 2016.