Skin CancerEarly Phase 1NCT00535769
Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
A Early Phase 1 study testing Electronic + no text message and Electronic monitor + text messages in people with Skin Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows: 1. To determine whether the use of electronic reminder system increases adherence to topical agents. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Electronic + no text message and Electronic monitor + text messages
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Nov 2007
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older at time of consent, may be men or women.
- Capable of giving informed consent
- Have a cellular phone capable of receiving text messages.
- Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Non-English speaking individuals
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:
- To determine whether the use of electronic reminder system increases adherence to topical agents.
- To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
- To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
- To obtain subjects' feedback on the adherence monitoring and reminder system.
Read the detailed description
We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.
- Conditions
- Skin Cancer
- Being tested
- Electronic + no text message, Electronic monitor + text messages
- Keywords
- topical, medication adherence, adherence, compliance, medication compliance, sunscreen, reminder
- Medical subject headings
- Skin Neoplasms, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic + no text messageDevice
Also called Electronic monitor without text messages
Electronic monitor is attached but no text-messages are sent through cellular phones
Electronic monitor + text messagesDevice
Also called Electronic monitor with text message
Electronic monitor is attached and text messages are sent through cellphone to remind sunscreen use
| Study group | Role | What they receive |
|---|---|---|
| Electronic monitor + no text message | Placebo comparator | The control or placebo comparator group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. Receives: Device: Electronic + no text message |
| Electronic monitor + Text message | Experimental | The text message experimental group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. Receives: Device: Electronic monitor + text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days the Subjects Are Adherent to Using Sunscreen
Participants' adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.
Measured: 6 weeks
Secondary outcomes (2)
Usefulness of Text Messaging System
Patients with the text message reminder system were asked their opinion on their satisfaction/ improved adherence to sunscreen application with the use of the messaging system on a scale of 0 to 10 (0, not useful at all; 10,most useful)
Measured: 6 weeks
Recalled Frequency of Sunscreen Application
The participants were asked to recall their frequency of sunscreen application based on a 5 point scale (0 never used sunscreen,; 1 forgot to apply 3x weekly,; 2 forgot to apply 1-2x weekly; 3 forgot to apply 1-2x per month; 4 always remembered)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 2007
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 (1)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexa B Kimball, MD MPH, Principal investigator, Brigham and Women's Hospital and Massachusetts General HospitalApril W Armstrong, MD, Study director, Brigham and Women's Hospital and Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535769
- Sponsor's protocol ID
- 2007-P-001456
- Status last verified
- Jul 2012
- First submitted
- 24 Sep 2007
- Last updated
- 20 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
PubMed 19917951
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence to Topical Agents: Applying Communication Technology to Improve Sunscreen Use
- ClinicalTrials.gov ID
- NCT00535769
- Acronym / sponsor ID
- 2007-P-001456
- Conditions
- Skin Cancer
- Keywords
- topical, medication adherence, adherence, compliance, medication compliance, sunscreen, reminder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 18 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if using an electronic reminder improves adherence to sunscreen use. The specific study aims are as follows:
- To determine whether the use of electronic reminder system increases adherence to topical agents.
- To assess technological feasibility of measuring adherence to topical agents using electronic monitors specially designed for tubes.
- To assess technological feasibility of providing electronic reminders using cellular phone text-messaging system.
- To obtain subjects' feedback on the adherence monitoring and reminder system.
Detailed description
We propose to use communication technology to develop a novel means of monitoring and improving adherence to topical agents. We will conduct a randomized, single-blinded, controlled trial to assess the impact of automated reminder system on adherence rates to sunscreens. This study will involve designing an electronic monitoring device specifically for topical agents and creating a platform for an automated reminder system. The electronic monitoring devices will be adaptable to tubes of varying shapes and sizes, and they will send SMS messages to a central server in real-time each time the tube is opened. We will create a text-message reminder system to send reminders to users' cellular phones over a secured network. Our hypothesis is that the electronic monitoring and reminder system will increase patients' adherence to topical agents. We will measure the impact of the intervention on adherence rates and assess patients' views on the reminder system. This project will allow us to engineer a novel device to electronically monitor adherence to topical agents and to use communication technology to change patients' behavior.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic monitor + no text message | Placebo comparator | Device: Electronic + no text messageThe control or placebo comparator group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. |
| Electronic monitor + Text message | Experimental | Device: Electronic monitor + text messagesThe text message experimental group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older at time of consent, may be men or women.
- Capable of giving informed consent
- Have a cellular phone capable of receiving text messages.
- Able to adhere to the study visit schedule and other protocol requirements.
Key exclusion criteria (1 listed)
- Non-English speaking individuals
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 |
|---|---|---|
| Electronic + no text messageAlso: Electronic monitor without text messagesElectronic monitor is attached but no text-messages are sent through cellular phones | Device | Electronic monitor + no text message |
| Electronic monitor + text messagesAlso: Electronic monitor with text messageElectronic monitor is attached and text messages are sent through cellphone to remind sunscreen use | Device | Electronic monitor + Text message |
Primary outcome
Number of Days the Subjects Are Adherent to Using Sunscreen
Time frame: 6 weeks
Participants' adherence was captured in real time using transmitting electronic monitors. At the end of the 6 week trial, the mean number of days the subjects are adherent to using sunscreen were compared.
2 secondary outcomes
Usefulness of Text Messaging System
Time frame: 6 weeks
Recalled Frequency of Sunscreen Application
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19917951Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
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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.
Alexa B Kimball, MD MPH principal investigator
Brigham and Women's Hospital and Massachusetts General Hospital
April W Armstrong, MD study director
Brigham and Women's Hospital and Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electronic + no text message and Electronic monitor + text messages in people with Skin Cancer, run by Massachusetts General Hospital 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 4 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 20 Jul 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2012). 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?
Number of Days the Subjects Are Adherent to Using Sunscreen (time frame: 6 weeks). 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 NCT00535769, 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 20 Jul 2012.