DepressionNCT02765542
Developing Accessible mHealth Programs for Depression Management in Bolivia
A study testing Automated disease assessment & self-care support phone calls in people with Depression, run by University of Michigan at 1 site in Bolivia.
Trial summary
The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Automated disease assessment & self-care support phone calls
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBolivia
- Study dates
- Jul 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
- PHQ-8 score of 10 or higher
Who cannot join
- Have diagnoses indicating a six-month life expectancy
- Prior inpatient psychiatric treatment
- Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
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 potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.
Read the detailed description
All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. 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, if possible, 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 who will be present.
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 12 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.
- Conditions
- Depression
- Being tested
- Automated disease assessment & self-care support phone calls
- Keywords
- Depression, mHealth, Interactive Voice Response, Bolivia, Mental health
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated disease assessment & self-care support phone callsOther
Automated disease assessment \& self-care support phone calls for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Automated phone calls | Experimental | Automated disease assessment \& self-care support phone calls for up to 12 weeks. Receives: Other: Automated disease assessment & self-care support phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Measured: Baseline and 12 week post-intervention follow-up
Secondary outcomes (4)
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
Measured: Baseline and 12 week post-intervention follow-up
Evaluate program feasibility (telephone call completion rates)
Measured: 12 week post-intervention follow-up
Patient satisfaction (satisfaction questionnaire)
Measured: 12 week Post-intervention follow-up
Patient qualitative feedback (qualitative questionnaire)
Measured: 12 week Post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT02765542
- Sponsor's protocol ID
- HUM00087937
- Status last verified
- May 2016
- First submitted
- 4 Mar 2015
- Last updated
- 6 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 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Accessible mHealth Programs for Depression Management in Bolivia
- ClinicalTrials.gov ID
- NCT02765542
- Acronym / sponsor ID
- HUM00087937
- Conditions
- Depression
- Keywords
- Depression, mHealth, Interactive Voice Response, Bolivia, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 May 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.
The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.
Detailed description
All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. 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, if possible, 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 who will be present.
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 12 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Automated phone calls | Experimental | Other: Automated disease assessment & self-care support phone callsAutomated disease assessment \& self-care support phone calls for up to 12 weeks. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 21-80 years of age
- PHQ-8 score of 10 or higher
Key exclusion criteria (3 listed)
- Have diagnoses indicating a six-month life expectancy
- Prior inpatient psychiatric treatment
- Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
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 |
|---|---|---|
| Automated disease assessment & self-care support phone callsAutomated disease assessment \& self-care support phone calls for up to 12 weeks. | Other | Automated phone calls |
Primary outcome
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
Time frame: Baseline and 12 week post-intervention follow-up
4 secondary outcomes
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
Time frame: Baseline and 12 week post-intervention follow-up
Evaluate program feasibility (telephone call completion rates)
Time frame: 12 week post-intervention follow-up
Patient satisfaction (satisfaction questionnaire)
Time frame: 12 week Post-intervention follow-up
Patient qualitative feedback (qualitative questionnaire)
Time frame: 12 week Post-intervention follow-up
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 6 May 2016.
- Individual participant dataSharing planned: No
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Survivorship
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 Automated disease assessment & self-care support phone calls in people with Depression, 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 2 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 6 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 depressive symptoms at 12 weeks (PHQ-8 Scores) (time frame: Baseline and 12 week post-intervention follow-up). 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 6 May 2016.