DiabetesNCT02806700

Twitter and Diabetes

A study testing Twitter Diabetes Intervention in people with Diabetes and Cardiovascular Disease, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes, Cardiovascular Disease
What is being tested?: Twitter Diabetes Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 628 participants
Where: 1 siteUnited States
Study dates: Jun 2016to Aug 2018
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 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

diabetes
uses social media

Who cannot join

<21 years of age
pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Twitter use is surprisingly well represented across broad demographic population segments and health-related messages. The promise of using Twitter is that its use is growing rapidly, it allows the investigators to view communications that were impossible to intercept before, and it potentially provides information faster and less expensively than collection from other media channels. Prior work also supports that social media interventions can improve health behavior change (e.g. weight loss, physical activity) and outcomes.The overarching goals of this proposal are to understand the uses and limitations of this communication channel to improve patients' ability to manage their CV health condition.

Read the detailed description

Use Twitter to deliver high impact CV health related content to improve patient activation and disease management for diabetes.

Conditions: Diabetes, Cardiovascular Disease
Being tested: Twitter Diabetes Intervention
Keywords: Diabetes, Social Media
Medical subject headings: Diabetes Mellitus, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Twitter Diabetes InterventionBehavioural
This group will be asked to use twitter for heart health ( e.g. tweeting, following, receiving tweets)

Study groups in NCT02806700
Study group	Role	What they receive
Twitter Diabetes Control	No intervention	This group will be identified as having diabetes from Twitter. This group will be contacted and asked to complete brief surveys
Twitter Diabetes Intervention	Experimental	This group will be identified as having diabetes from Twitter. This group will be contacted and asked to complete brief surveys. This group will be asked to use twitter for heart health ( e.g. tweeting, following, receiving tweets) Receives: Behavioral: Twitter Diabetes Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Patient Activation Measure (PAM) Score From Baseline
The Patient Activation Measure (PAM) is a validated and reliable tool that assesses a person's ability to manage their health, using a 100-point total score scale and four activation levels. The total score ranges from 0 to 100, with higher scores indicating better outcomes-specifically, higher scores represent better outcomes. The overall score is summed from individual items, reflecting the level of activation and self-management ability. The four levels are:
Level 1 (Score: 0-47.0): Lowest activation, indicating disengagement and lack of confidence in managing health.
Level 2 (Score: 47.1-55.1): Some awareness of self-management but limited skills and confidence.
Level 3 (Score: 55.2-67.0): Actively trying to manage health but inconsistent success.
Level 4 (Score: 67.1-100): Highest activation, indicating confidence and proactive health management.
Measured: baseline and 6 months

Secondary outcomes (1)

Change in Systolic Blood Pressure From Baseline
Initial systolic blood pressure (SBP) measurements were obtained from the electronic medical record (EMR). For the majority of patients, final blood pressure measurements (i.e., the 6-month measurement) were obtained in a five to eight month period after enrollment from a documented reading in the the EMR.
For patients who did not have a documented SBP reading in the health system during this time period, we requested that patients either meet our team in person for a manual reading or provide a photograph from their mobile phone of the screen showing their SBP reading from a home blood pressure cuff, pharmacy machine, or doctor's office from outside of our health system.
Measured: baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Aug 2018

First posted21 Jun 2016 (estimated)
Study startJun 2016
Primary completionMay 2018
Study completionAug 2018

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.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02806700
Sponsor's protocol ID: R01: HL122457-0IA1
Other IDs: R01HL122457-01A1
Status last verified: Oct 2024
First submitted: 16 Jun 2016
Last updated: 21 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Twitter and Diabetes
ClinicalTrials.gov ID: NCT02806700
Acronym / sponsor ID: R01: HL122457-0IA1
Conditions: Diabetes, Cardiovascular Disease
Keywords: Diabetes, Social Media
Study type: Interventional
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Jun 2016 (actual)
Primary completion: May 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 21 Jun 2016 (estimated)
Results: Posted 21 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Use Twitter to deliver high impact CV health related content to improve patient activation and disease management for diabetes.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Twitter Diabetes Control	No intervention	–This group will be identified as having diabetes from Twitter. This group will be contacted and asked to complete brief surveys
Twitter Diabetes Intervention	Experimental	Behavioral: Twitter Diabetes InterventionThis group will be identified as having diabetes from Twitter. This group will be contacted and asked to complete brief surveys. This group will be asked to use twitter for heart health ( e.g. tweeting, following, receiving tweets)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

diabetes
uses social media

Key exclusion criteria (2 listed)

<21 years of age
pregnant

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
Twitter Diabetes InterventionThis group will be asked to use twitter for heart health ( e.g. tweeting, following, receiving tweets)	Behavioural	Twitter Diabetes Intervention

Primary outcome

Change in Patient Activation Measure (PAM) Score From Baseline
Time frame: baseline and 6 months
The Patient Activation Measure (PAM) is a validated and reliable tool that assesses a person's ability to manage their health, using a 100-point total score scale and four activation levels. The total score ranges from 0 to 100, with higher scores indicating better outcomes-specifically, higher scores represent better outcomes. The overall score is summed from individual items, reflecting the level of activation and self-management ability. The four levels are: Level 1 (Score: 0-47.0): Lowest activation, indicating disengagement and lack of confidence in managing health. Level 2 (Score: 47.1-55.1): Some awareness of self-management but limited skills and confidence. Level 3 (Score: 55.2-67.0): Actively trying to manage health but inconsistent success. Level 4 (Score: 67.1-100): Highest activation, indicating confidence and proactive health management.

1 secondary outcome

Change in Systolic Blood Pressure From Baseline
Time frame: baseline and 6 months

Results and safety

Results posted to the registry on 21 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Twitter Diabetes Control	316	226
Twitter Diabetes Intervention	312	252

Primary outcome: Change in Patient Activation Measure (PAM) Score From Baseline

Time frame: baseline and 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Twitter Diabetes Control n = 202	Twitter Diabetes Intervention n = 129
Value	3.4 (17.4)	0.0 (20.7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twitter Diabetes Control	0 of 0	0 of 0	0
Twitter Diabetes Intervention	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The actual impact of regular tweeting about health may not have been fully actualized in this study. Creating de novo content requires a certain amount of inertia, and prior work shows that individuals engage on social media as passive consumers. The study design was intended to be pragmatic and model real-world use of social media, we did not provide any additional nudges, and although a weekly reminder was useful, participants may have needed feedback on how their tweets were being received.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes

RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes

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 Twitter Diabetes Intervention in people with Diabetes and Cardiovascular Disease, 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 2 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: finished, as of the sponsor's last update on 21 Oct 2024. 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?

Yes. Results are posted in the registry (first posted 21 Oct 2024). 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?

Change in Patient Activation Measure (PAM) Score From Baseline (time frame: baseline and 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 NCT02806700.

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 21 Oct 2024.