Kidney TransplantationNCT02827695
Smart Phone Medication Adherence Saves Kidneys--SMASK
A study testing SMASK and EnhancedSC in people with Kidney Transplantation and Medication Adherence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Kidney Transplantation, Medication Adherence, Hypertension
- What is being tested?
- SMASK and EnhancedSC
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 31 Aug 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 years old;
- First time recipient of a functioning solitary kidney transplant;
- Prescribed ≥3 medications for immunosuppression and HTN;
- Transplant MD's assent that patient is able to participate;
- Ability to speak, hear and understand English;
- Able to take their own BP;
Show all 9Show fewer
- Self-administers medications;
- SBP >129 mmHg at clinic visit(s) in 4 weeks prior, and at initial study evaluation at enrollment;
- ***Only subjects with adherence score <.85 after 1-month screening and SBP >129 mmHg at baseline will be randomized.
Who cannot join
- Failure to meet any inclusion criterion;
- Ongoing substance abuse (e.g., >21 alcoholic drinks/week);
- Psychiatric illness requiring treatment beyond antidepressants;
- Will attempt to become pregnant within the year;
- Pregnant or nursing women, prisoners, and institutionalized persons.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.
Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Read the detailed description
A randomized RCT will be conducted with kidney transplant patients identified as hypertensive (>129 SBP following KDIGO guidelines) via medical history. Those identified as being nonadherent for 4 weeks during the first month post enrollment (adherence score <0.85) will be eligible to participate in the second phase. Participants in the second phase will be randomly assigned to standard care (SC) + attention control or the mHealth program plus SC.
Following informed written consent, eligible patients will be asked to complete several brief surveys aimed at determining, mood state, perceived stress, self-efficacy assessment, comfort with mHealth devices, perceptions of treatment burden and attitudes towards mhealth. Subjects will have their blood pressure measured and if SBP is >129 they will enter the screening phase. Subjects will be provided a Medication dispensing device system. Subjects will be called the following day to check if there were any problems in filling the Simplemed tray.
The Simplemed has four compartments for each day of the week for potential use. Microelectronic circuitry in each compartment on the tray date stamps the opening of each compartment and removal of the refill tray. These signals are relayed via an internal modem to a server for processing. Data can then be sent directly into the MUSC server that compiles individuals' health data from multiple delivery points. Adherence rate across the first month will be calculated at weekly intervals.
All subjects will return for a visit at the end of their 4 week screening period. Those with an adherence score <0.85 for 4 weeks and whose SBP continues to be >129 will be invited to participate in the second phase of the RCT. Evaluations performed at this visit will include anthropometrics, questionnaires, and resting BP. A Spacelabs ABP monitor will be applied with instructions for wearing the monitor 24 hrs. The subjects will be randomized to SMASK+SC or SC+ attention control groups after the baseline procedures are completed. Those with med adherence score ≥0.85 or who have SBP ≤ 129 will return their pill tray but not proceed into the second phase. Recruitment will end when 80 subjects have successfully transitioned into the second phase (RCT) of the study.
The SC+ attention control group will continue to use Simplemed with reminder functions disabled, they will be sent daily text messages or links to PDF documents or videos containing health information as attention control. The SMASK mhealth intervention group will also receive SC and have the Simplemed reminder functions turned on (blink for ½ hr when medication is due, chime additional ½ hr, then text or email after 1 hour) and receive training in use of the A\&D BP monitor. They will be instructed to measure their blood pressure twice daily AM, PM) on at least every third day. Patients will be provided with and shown how to use the smart phone app and activate the app when they record their blood pressure readings.
- Conditions
- Kidney Transplantation, Medication Adherence, Hypertension
- Being tested
- SMASK, EnhancedSC
- Medical subject headings
- Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMASKBehavioural
Medication adherence and BP monitoring
EnhancedSCBehavioural
Standard care without med reminder functions with healthy lifestyle texts
| Study group | Role | What they receive |
|---|---|---|
| SMASK | Experimental | Subjects will receive electronic pill tray with reminder functions activated and Bluetooth blood pressure monitor and phone app. Receives: Behavioral: SMASK |
| EnhancedSC | Other | Subjects will receive daily attention control texts with healthy lifestyle information and continue to use the pill tray without reminder functions. Receives: Behavioral: EnhancedSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
% with electronic monitor-derived adherence scores >.90;
Measured: six months
Secondary outcomes (3)
Provider adherence to KDIGO guidelines
measured by timing of medication changes
Measured: six months
Changes in Self-Determination Theory mediators
Survey responses demonstrate increased (e.g., perceived competence and autonomous regulation).
Measured: six months
BP control
% reaching and sustaining Kidney Disease Improving Global Outcomes (KDIGO) guidelines for BP control (resting and 24-hr BP<130/80 mmHg).
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2020
- Study completion31 Aug 2020
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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John McGillicuddy, MD, Principal investigator, MUSC Transplant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827695
- Sponsor's protocol ID
- Pro00053471
- Status last verified
- Oct 2020
- First submitted
- 6 Jul 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Phone Medication Adherence Saves Kidneys--SMASK
- ClinicalTrials.gov ID
- NCT02827695
- Acronym / sponsor ID
- Pro00053471
- Conditions
- Kidney Transplantation, Medication Adherence, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 11 Jul 2016 (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.
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.
Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Detailed description
A randomized RCT will be conducted with kidney transplant patients identified as hypertensive (>129 SBP following KDIGO guidelines) via medical history. Those identified as being nonadherent for 4 weeks during the first month post enrollment (adherence score <0.85) will be eligible to participate in the second phase. Participants in the second phase will be randomly assigned to standard care (SC) + attention control or the mHealth program plus SC.
Following informed written consent, eligible patients will be asked to complete several brief surveys aimed at determining, mood state, perceived stress, self-efficacy assessment, comfort with mHealth devices, perceptions of treatment burden and attitudes towards mhealth. Subjects will have their blood pressure measured and if SBP is >129 they will enter the screening phase. Subjects will be provided a Medication dispensing device system. Subjects will be called the following day to check if there were any problems in filling the Simplemed tray.
The Simplemed has four compartments for each day of the week for potential use. Microelectronic circuitry in each compartment on the tray date stamps the opening of each compartment and removal of the refill tray. These signals are relayed via an internal modem to a server for processing. Data can then be sent directly into the MUSC server that compiles individuals' health data from multiple delivery points. Adherence rate across the first month will be calculated at weekly intervals.
All subjects will return for a visit at the end of their 4 week screening period. Those with an adherence score <0.85 for 4 weeks and whose SBP continues to be >129 will be invited to participate in the second phase of the RCT. Evaluations performed at this visit will include anthropometrics, questionnaires, and resting BP. A Spacelabs ABP monitor will be applied with instructions for wearing the monitor 24 hrs. The subjects will be randomized to SMASK+SC or SC+ attention control groups after the baseline procedures are completed. Those with med adherence score ≥0.85 or who have SBP ≤ 129 will return their pill tray but not proceed into the second phase. Recruitment will end when 80 subjects have successfully transitioned into the second phase (RCT) of the study.
The SC+ attention control group will continue to use Simplemed with reminder functions disabled, they will be sent daily text messages or links to PDF documents or videos containing health information as attention control. The SMASK mhealth intervention group will also receive SC and have the Simplemed reminder functions turned on (blink for ½ hr when medication is due, chime additional ½ hr, then text or email after 1 hour) and receive training in use of the A\&D BP monitor. They will be instructed to measure their blood pressure twice daily AM, PM) on at least every third day. Patients will be provided with and shown how to use the smart phone app and activate the app when they record their blood pressure readings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMASK | Experimental | Behavioral: SMASKSubjects will receive electronic pill tray with reminder functions activated and Bluetooth blood pressure monitor and phone app. |
| EnhancedSC | Other | Behavioral: EnhancedSCSubjects will receive daily attention control texts with healthy lifestyle information and continue to use the pill tray without reminder functions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥21 years old;
- First time recipient of a functioning solitary kidney transplant;
- Prescribed ≥3 medications for immunosuppression and HTN;
- Transplant MD's assent that patient is able to participate;
- Ability to speak, hear and understand English;
Key exclusion criteria (5 listed)
- Failure to meet any inclusion criterion;
- Ongoing substance abuse (e.g., >21 alcoholic drinks/week);
- Psychiatric illness requiring treatment beyond antidepressants;
- Will attempt to become pregnant within the year;
- Pregnant or nursing women, prisoners, and institutionalized persons.
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 |
|---|---|---|
| SMASKMedication adherence and BP monitoring | Behavioural | SMASK |
| EnhancedSCStandard care without med reminder functions with healthy lifestyle texts | Behavioural | EnhancedSC |
Primary outcome
Medication Adherence
Time frame: six months
% with electronic monitor-derived adherence scores >.90;
3 secondary outcomes
Provider adherence to KDIGO guidelines
Time frame: six months
Changes in Self-Determination Theory mediators
Time frame: six months
BP control
Time frame: Six 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 22 Oct 2020.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Individual participant dataSharing planned: No
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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.
John McGillicuddy, MD principal investigator
MUSC Transplant Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMASK and EnhancedSC in people with Kidney Transplantation and Medication Adherence, run by Medical University of South Carolina 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 9 inclusion and 5 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 22 Oct 2020. 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 Adherence (time frame: six 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 NCT02827695, 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 22 Oct 2020.