HypertensionNCT02429297
Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia
A study testing HITCM-only and HITCM+CP in people with Hypertension and Diabetes, run by University of Michigan at 1 site in Bolivia.
Trial summary
The purpose of the study is to evaluate the feasibility and impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of support from a family member or friend. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- HITCM-only and HITCM+CP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBolivia
- Study dates
- Jun 2014to Dec 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21-80 years of age
- Diagnosis of hypertension, a systolic blood pressure > 140mmHg, and/or diagnosis of diabetes
- Access to a functional cell phone
- Able to respond to automated telephone calls
Who cannot join
- Life-threatening health problem such as cancer with less than a six month life expectancy
- Are visiting the clinic for an urgent health problem (for themselves)
- If they have severe mental illness as reported by their clinical team
Trial locations and contacts
1 site in 1 country.
Bolivia1 site
El Servicio Departmental de Salud (SEDES) affiliated clinics
La Paz
About this study
The purpose of the study is to evaluate the feasibility and impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of support from a family member or friend.
Read the detailed description
All patients will receive weekly automated calls with feedback to the clinical team. Blood pressures will be taken for all patients by researchers and finger-stick blood glucose readings will be taken at baseline for diabetic patients only and if possible, at follow-up. Fingersticks will use the patient's own glucometer or standard home glucometers donated by the project to the clinic. Patients will be informed about their blood pressure results; and, the clinic will be alerted if the systolic BP exceeds 150.
If participants enroll with a CarePartner, they will be randomized to have their CarePartner receive weekly automated updates focused on symptom monitoring and patient self-care (HITCM+CP) versus usual care (no updates to CarePartner), HITCM-only. All participants will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 16 weeks. Some patients with hypertension may be provided with in-home cuffs for measurement of blood pressure throughout the study. During enrollment, the research team will explain how the cuffs are used, as well as how to work the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, blood pressure regimen and readings (hypertension only), diet, glucose monitoring and symptoms of high/low blood sugar (diabetes only) and medication adherence. Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. No identifying information is included in the automated call sent to the patient's phone other than the patient's first name. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate.
In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.
The intervention will last up to 16 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone. Patients will receive an incentive at follow-up at no more than $10 USD.
- Conditions
- Hypertension, Diabetes
- Being tested
- HITCM-only, HITCM+CP
- Keywords
- Hypertension, Diabetes, mHealth, Interactive Voice Response, Bolivia, Chronic disease
- Medical subject headings
- Hypertension, Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITCM-onlyOther
HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.
HITCM+CPOther
HITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email.
| Study group | Role | What they receive |
|---|---|---|
| Patient Only - HITCM-only | Experimental | Patients enrolling without a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team. Receives: Other: HITCM-only |
| Patient & CarePartner - HITCM-only | Experimental | Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team. Receives: Other: HITCM-only |
| Patient & CarePartner - HITCM+CP | Experimental | Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team plus updates to their CarePartner via phone or email. Receives: Other: HITCM+CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)
Measured: Up to 16 weeks
Secondary outcomes (2)
Patient satisfaction (satisfaction questionnaire)
Measured: Up to 16 weeks
Evaluate program feasibility (questionnaire, satisfaction, and usage rates)
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Piette, University of Michigan
- Investigators
- John D Piette, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429297
- Sponsor's protocol ID
- HUM00081734
- Status last verified
- May 2016
- First submitted
- 4 Mar 2015
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia
- ClinicalTrials.gov ID
- NCT02429297
- Acronym / sponsor ID
- HUM00081734
- Conditions
- Hypertension, Diabetes
- Keywords
- Hypertension, Diabetes, mHealth, Interactive Voice Response, Bolivia, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 2015 (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.
The purpose of the study is to evaluate the feasibility and impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of support from a family member or friend.
Detailed description
All patients will receive weekly automated calls with feedback to the clinical team. Blood pressures will be taken for all patients by researchers and finger-stick blood glucose readings will be taken at baseline for diabetic patients only and if possible, at follow-up. Fingersticks will use the patient's own glucometer or standard home glucometers donated by the project to the clinic. Patients will be informed about their blood pressure results; and, the clinic will be alerted if the systolic BP exceeds 150.
If participants enroll with a CarePartner, they will be randomized to have their CarePartner receive weekly automated updates focused on symptom monitoring and patient self-care (HITCM+CP) versus usual care (no updates to CarePartner), HITCM-only. All participants will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 16 weeks. Some patients with hypertension may be provided with in-home cuffs for measurement of blood pressure throughout the study. During enrollment, the research team will explain how the cuffs are used, as well as how to work the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, blood pressure regimen and readings (hypertension only), diet, glucose monitoring and symptoms of high/low blood sugar (diabetes only) and medication adherence. Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. No identifying information is included in the automated call sent to the patient's phone other than the patient's first name. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate.
In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.
The intervention will last up to 16 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone. Patients will receive an incentive at follow-up at no more than $10 USD.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Only - HITCM-only | Experimental | Other: HITCM-onlyPatients enrolling without a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team. |
| Patient & CarePartner - HITCM-only | Experimental | Other: HITCM-onlyPatients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team. |
| Patient & CarePartner - HITCM+CP | Experimental | Other: HITCM+CPPatients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team plus updates to their CarePartner via phone or email. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21-80 years of age
- Diagnosis of hypertension, a systolic blood pressure > 140mmHg, and/or diagnosis of diabetes
- Access to a functional cell phone
- Able to respond to automated telephone calls
Key exclusion criteria (3 listed)
- Life-threatening health problem such as cancer with less than a six month life expectancy
- Are visiting the clinic for an urgent health problem (for themselves)
- If they have severe mental illness as reported by their clinical team
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 |
|---|---|---|
| HITCM-onlyHITCM-only group: patients receive weekly automated calls with feedback to the clinical team. | Other | Patient & CarePartner - HITCM-only, Patient Only - HITCM-only |
| HITCM+CPHITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email. | Other | Patient & CarePartner - HITCM+CP |
Primary outcome
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)
Time frame: Up to 16 weeks
2 secondary outcomes
Patient satisfaction (satisfaction questionnaire)
Time frame: Up to 16 weeks
Evaluate program feasibility (questionnaire, satisfaction, and usage rates)
Time frame: Up to 16 weeks
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 5 May 2016.
- 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 D Piette, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HITCM-only and HITCM+CP in people with Hypertension and Diabetes, run by University of Michigan at 1 site in Bolivia.
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 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 5 May 2016. 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 Bolivia. 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?
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire) (time frame: Up to 16 weeks). 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 5 May 2016.