Kidney Transplant; ComplicationsNCT03426280
Activity Therapy After Kidney Transplant
A study testing Apple Watch Series 1 in people with Kidney Transplant; Complications, run by Stanford University at 1 site in United States.
Trial summary
To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications
- What is being tested?
- Apple Watch Series 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults (18 years) who undergo kidney transplant at Stanford.
Who cannot join
- Poor vision with inability to use Apple Watch
- Permanently unable to ambulate
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinic
Palo Alto, California, 94304
About this study
Official title: Activity Therapy After Kidney Transplant: A Pilot Study
To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch.
- Conditions
- Kidney Transplant; Complications
- Being tested
- Apple Watch Series 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Watch Series 1Device
Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Apple Watch | Experimental | Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months. Receives: Device: Apple Watch Series 1 |
| Usual Care | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Level (daily caloric consumption)
Measured: 1 year
% Days using Apple Watch
Measured: 1st year of transplant
Secondary outcomes (2)
Weight
Measured: 1st year of transplant
Hemoglobin A1c
Measured: 1st year of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 May 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: Study closed due to Covid-19 health emergency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Apple Inc.
- Responsible party
- Principal investigator, Xingxing Shelley Cheng, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426280
- Sponsor's protocol ID
- 44663
- Status last verified
- Jun 2023
- First submitted
- 2 Feb 2018
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Therapy After Kidney Transplant: A Pilot Study
- ClinicalTrials.gov ID
- NCT03426280
- Acronym / sponsor ID
- 44663
- Conditions
- Kidney Transplant; Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to Covid-19 health emergency
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Apple Inc.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 8 Feb 2018 (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.
To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple Watch | Experimental | Device: Apple Watch Series 1Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months. |
| Usual Care | No intervention | –Usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults (18 years) who undergo kidney transplant at Stanford.
Key exclusion criteria (2 listed)
- Poor vision with inability to use Apple Watch
- Permanently unable to ambulate
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 |
|---|---|---|
| Apple Watch Series 1Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months. | Device | Apple Watch |
Primary outcome
Activity Level (daily caloric consumption)
Time frame: 1 year
% Days using Apple Watch
Time frame: 1st year of transplant
2 secondary outcomes
Weight
Time frame: 1st year of transplant
Hemoglobin A1c
Time frame: 1st year of transplant
Results and safety
The study was stopped early (reason given: Study closed due to Covid-19 health emergency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Watch Series 1 in people with Kidney Transplant; Complications, run by Stanford University 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 2 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: stopped early, as of the sponsor's last update on 27 Jun 2023. 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 was stopped early (reason given: Study closed due to Covid-19 health emergency). Results are not available in the source record.
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?
Activity Level (daily caloric consumption) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 27 Jun 2023.