Adherence to Medication RegimeNCT02157519
Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
A study testing Mobile Application Intervention in people with Adherence to Medication Regime and Cancer, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence to Medication Regime, Cancer
- What is being tested?
- Mobile Application Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Feb 2015to 31 Dec 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient Participant Inclusion Criteria
- Age greater than 18 years
- Diagnosis of cancer with a new or existing prescription for oral chemotherapy
- Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore or Emerson Hospitals)
- Eastern Cooperative Oncology Group (ECOG) ranging from 0 (asymptomatic) to 2 (symptomatic and in bed >50% of the day)
- Able to read and respond to questions in English
Show all 12Show fewer
- Uses smart mobile phone (either operating system (iOS) [iPhone] or Android device)
- Clinician Participant Inclusion Criteria - Clinician participants must be oncology clinicians (i.e. physicians and nurse practitioners) who maintain at least 25% clinical practice at the Massachusetts General Hospital Cancer Center or one of its community affiliates at the North Shore or Emerson Hospital.
- Stakeholder Participant Inclusion Criteria - Four groups of stakeholders will provide ongoing feedback about the study design, methods, and results. To be eligible as a stakeholder, the participant must be able to represent the interests and perspective of at least one of the following stakeholder groups:
- Oncology Patient or Family Member
- Oncology Clinician (e.g., Physician or Nurse Practitioner)
- Cancer Practice Setting Administrator Health System, Community, and Society.
Who cannot join
- Patient Participant Exclusion Criteria
- Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis) or neurologic dysfunction will be excluded given that such symptoms would interfere with consent and participation.
- Individuals who own Windows or Blackberry smart mobile phones will not be eligible.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital/North Shore Cancer Center
Boston, Massachusetts, 01923
Massachusetts General Hospital
Boston, Massachusetts, 02114
Massachusetts General Hospital At Emerson Hospital-Bethke
Concord, Massachusetts, 01742
About this study
Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. The purpose of this study is to explore how a Smartphone mobile application ("mobile app") can help improve the cancer treatment process in people who are prescribed oral chemotherapy medication. The investigators will explore how well the mobile app helps patients stay connected with their oncology care team, take their oral medications as prescribed, and manage their cancer-related symptoms from home. This study will be done in two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention, and 2) a randomized-controlled trial to test the intervention.
Read the detailed description
Background: Over the last decade, novel targeted agents have revolutionized the delivery of cancer care and improved survival rates, especially in those with metastatic disease. While oral chemotherapies possess significant advantages with respect to ease of administration, patients and caregivers receive less support for adherence and monitoring of side effects. Therefore, novel interventions are essential to help patients communicate in a more open and timely manner with their oncology clinicians to support adherence. As part of Phase 1 for this Patient-Centered Outcomes Research Institute (PCORI) grant, we conducted qualitative interviews with patients, clinicians and relevant stakeholders to inform the development of the proposed mobile app intervention. For the randomized-controlled trial, the investigators will recruit and randomly assign 180 adult patients prescribed oral chemotherapy to receive either the intervention (completed smartphone mobile app) or standard care.
Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of a mobile application to help improve adherence to oral chemotherapy and symptom to patients with cancer. We will administer the intervention at three cancer centers, hypothesizing that patients with who use the mobile app will report better adherence to their oral chemotherapy and better management of symptoms than those patients who were not assigned to the intervention.
Specific Aims: The primary aims of this study are 1) to implement a patient-centered mobile application to assess symptoms, side effects, and adherence to oral chemotherapy that is feasible for use in oncology patients, and 2) to evaluate the efficacy of the mobile application in improving patient-reported clinical outcomes.
Study Design: We will recruit and randomly assign 180 patients from the three cancer care sites who have recently been prescribed oral chemotherapy to receive either the mobile app intervention or standard care. Participants will be stratified by study site (i.e. Massachusetts General Hospital (MGH), North Shore, MGH West, and Emerson Cancer Centers), cancer type, and line of chemotherapy. This will ensure relatively equal percentages of patients from each study site, diagnosis, and line of chemotherapy will be represented in the treatment and control groups. The mobile app intervention which will consist of completing an initial chemotherapy treatment plan with their oncology clinicians, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses each week for 12 weeks. Medication adherence, symptom severity, and quality of life will serve as primary outcomes, and we will collect measures of quality cancer care as secondary targets. We will also explore whether particular patient characteristics (i.e. cancer type, demographics) affect patient response to the mobile app intervention.
- Conditions
- Adherence to Medication Regime, Cancer
- Being tested
- Mobile Application Intervention
- Keywords
- Oral Chemotherapy, Cancer
- Medical subject headings
- Medication Adherence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application InterventionOther
Participants assigned to the intervention group will receive the mobile application intervention for approximately three months after enrollment. The mobile app intervention will consist of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app will also be transmitted in real-time to the participants' oncology clinicians via a HIPAA-compliant, secure email.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Intervention | Experimental | Participants in the intervention group will receive the mobile application for improving symptoms and adherence to oral chemotherapy along with their standard oncology care. The proposed elements of the mobile application include the following: 1) specification of an oral chemotherapy treatment plan; 2) weekly collection of patient-reported symptoms and medication adherence; and 3) delivery of real-time, tailored feedback to patients as well as immediate transmission of survey results to oncology clinicians. Receives: Other: Mobile Application Intervention |
| Standard Oncology Care | No intervention | Participants in the control group will receive standard oncology care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week
The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate "yes" or "no" to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered "yes" to any of the four items were coded as having adherence problems, while those who indicated "no" to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week.
Measured: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
Adherence to Oral Chemotherapy Medication
Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.
Measured: Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
Change in Symptoms and Side Effects
M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being "not present" or "did not interfere" and 10 being "as bad as you can imagine" or "interfered completely". The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference.
Measured: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Change in Quality of Life
Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life.
Measured: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Secondary outcomes (3)
Treatment Satisfaction
Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interpersonal (3 items, range 0-9), comprehensive care (7 items; range 0-21), nurses (3 items; range 0-9), and trust (4 items; range 0-12). A higher score indicates greater satisfaction with care, while a lower score represents lower satisfaction with care.
Measured: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Emergency Department Visits
Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization.
Measured: Post-Assessment (12-14 weeks after baseline)
Hospitalizations
Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to "5 or more". Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization.
Measured: Post-Assessment (12-14 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start18 Feb 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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 Adherence to Medication RegimeStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph A. Greer, Ph.D., Massachusetts General Hospital
- Investigators
- Joseph Greer, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157519
- Sponsor's protocol ID
- 14-055
- Status last verified
- Apr 2018
- First submitted
- 4 Jun 2014
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198.
PubMed 28428158
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application for Improving Symptoms and Adherence to Oral Chemotherapy in Patients With Cancer
- ClinicalTrials.gov ID
- NCT02157519
- Acronym / sponsor ID
- 14-055
- Conditions
- Adherence to Medication Regime, Cancer
- Keywords
- Oral Chemotherapy, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people treated for cancer receive oral chemotherapy medications for their illness. This means that much of their cancer care occurs at home, away from a traditional oncology care setting. The purpose of this study is to explore how a Smartphone mobile application ("mobile app") can help improve the cancer treatment process in people who are prescribed oral chemotherapy medication. The investigators will explore how well the mobile app helps patients stay connected with their oncology care team, take their oral medications as prescribed, and manage their cancer-related symptoms from home. This study will be done in two phases: 1) a pilot phase to assess the feasibility of a mobile application intervention, and 2) a randomized-controlled trial to test the intervention.
Detailed description
Background: Over the last decade, novel targeted agents have revolutionized the delivery of cancer care and improved survival rates, especially in those with metastatic disease. While oral chemotherapies possess significant advantages with respect to ease of administration, patients and caregivers receive less support for adherence and monitoring of side effects. Therefore, novel interventions are essential to help patients communicate in a more open and timely manner with their oncology clinicians to support adherence. As part of Phase 1 for this Patient-Centered Outcomes Research Institute (PCORI) grant, we conducted qualitative interviews with patients, clinicians and relevant stakeholders to inform the development of the proposed mobile app intervention. For the randomized-controlled trial, the investigators will recruit and randomly assign 180 adult patients prescribed oral chemotherapy to receive either the intervention (completed smartphone mobile app) or standard care.
Objective/Hypothesis: The goals of this study are to assess the feasibility and efficacy of a mobile application to help improve adherence to oral chemotherapy and symptom to patients with cancer. We will administer the intervention at three cancer centers, hypothesizing that patients with who use the mobile app will report better adherence to their oral chemotherapy and better management of symptoms than those patients who were not assigned to the intervention.
Specific Aims: The primary aims of this study are 1) to implement a patient-centered mobile application to assess symptoms, side effects, and adherence to oral chemotherapy that is feasible for use in oncology patients, and 2) to evaluate the efficacy of the mobile application in improving patient-reported clinical outcomes.
Study Design: We will recruit and randomly assign 180 patients from the three cancer care sites who have recently been prescribed oral chemotherapy to receive either the mobile app intervention or standard care. Participants will be stratified by study site (i.e. Massachusetts General Hospital (MGH), North Shore, MGH West, and Emerson Cancer Centers), cancer type, and line of chemotherapy. This will ensure relatively equal percentages of patients from each study site, diagnosis, and line of chemotherapy will be represented in the treatment and control groups. The mobile app intervention which will consist of completing an initial chemotherapy treatment plan with their oncology clinicians, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses each week for 12 weeks. Medication adherence, symptom severity, and quality of life will serve as primary outcomes, and we will collect measures of quality cancer care as secondary targets. We will also explore whether particular patient characteristics (i.e. cancer type, demographics) affect patient response to the mobile app intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Intervention | Experimental | Other: Mobile Application InterventionParticipants in the intervention group will receive the mobile application for improving symptoms and adherence to oral chemotherapy along with their standard oncology care. The proposed elements of the mobile application include the following: 1) specification of an oral chemotherapy treatment plan; 2) weekly collection of patient-reported symptoms and medication adherence; and 3) delivery of real-time, tailored feedback to patients as well as immediate transmission of survey results to oncology clinicians. |
| Standard Oncology Care | No intervention | –Participants in the control group will receive standard oncology care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient Participant Inclusion Criteria
- Age greater than 18 years
- Diagnosis of cancer with a new or existing prescription for oral chemotherapy
- Receiving cancer care at either Massachusetts General Hospital Cancer Center or community affiliates (North Shore or Emerson Hospitals)
- Eastern Cooperative Oncology Group (ECOG) ranging from 0 (asymptomatic) to 2 (symptomatic and in bed >50% of the day)
Key exclusion criteria (3 listed)
- Patient Participant Exclusion Criteria
- Individuals with co-morbid acute or untreated psychiatric symptoms (e.g., psychosis) or neurologic dysfunction will be excluded given that such symptoms would interfere with consent and participation.
- Individuals who own Windows or Blackberry smart mobile phones will not be eligible.
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 |
|---|---|---|
| Mobile Application InterventionParticipants assigned to the intervention group will receive the mobile application intervention for approximately three months after enrollment. The mobile app intervention will consist of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app will also be transmitted in real-time to the participants' oncology clinicians via a HIPAA-compliant, secure email. | Other | Mobile Application Intervention |
Primary outcome
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week
Time frame: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment
The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate "yes" or "no" to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered "yes" to any of the four items were coded as having adherence problems, while those who indicated "no" to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week.
Adherence to Oral Chemotherapy Medication
Time frame: Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)
Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.
Change in Symptoms and Side Effects
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being "not present" or "did not interfere" and 10 being "as bad as you can imagine" or "interfered completely". The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference.
Change in Quality of Life
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life.
3 secondary outcomes
Treatment Satisfaction
Time frame: Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)
Emergency Department Visits
Time frame: Post-Assessment (12-14 weeks after baseline)
Hospitalizations
Time frame: Post-Assessment (12-14 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28428158Fishbein JN, Nisotel LE, MacDonald JJ, Amoyal Pensak N, Jacobs JM, Flanagan C, Jethwani K, Greer JA. Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development. JMIR Res Protoc. 2017 Apr 20;6(4):e62. doi: 10.2196/resprot.6198.
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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.
Joseph Greer, Ph.D principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application Intervention in people with Adherence to Medication Regime and Cancer, run by Massachusetts General Hospital at 3 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 3 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 19 Nov 2018). 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?
Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week (time frame: Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment). The study lists 4 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 NCT02157519, 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 19 Nov 2018.