Treatment Adherence and ComplianceADHERANCT07445802
Medication Adherence in Severe Mental Illness: a Promotion Program
A study testing Telehealth Psychoeducational Adherence Program in people with Treatment Adherence and Compliance and Severe Mental Disorders, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
Trial summary
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence and Compliance, Severe Mental Disorders, Bipolar Disorder (BD)
- What is being tested?
- Telehealth Psychoeducational Adherence Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis established using ICD-11 clinical criteria [15].
- Aged 18 years or older.
- Registered on the Patient Portal.
- With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).
Who cannot join
- Aged under 18 years old.
- Unable to provide consent for medical or legal reasons.
- Not registered on the Patient Portal.
- No active prescription for antipsychotic drugs in the MUP.
About this study
Official title: Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias.
With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence.
Read more
The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence.
Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months.
If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions
Read the detailed description
This study aims to evaluate the validity of digital self-reported treatment adherence questionnaires in comparison with objective pharmacy dispensing records for antipsychotic medications, identify predictors of non-adherence, and assess the effectiveness of a telehealth intervention designed to improve adherence among adults with schizophrenia or bipolar disorder.
Study Design
The protocol incorporates three linked components:
Validation study: Sensitivity, specificity, predictive values, and ROC analysis will be used to determine the accuracy of digital adherence self-report scales compared with electronic dispensing data from the regional Single Prescription Module (MUP), considered the reference standard.
Observational study: Sociodemographic and clinical variables obtained through the Patient Portal will be analyzed to identify correlates of adherence. Logistic regression and correlation models will be applied to examine associations between treatment exposure (continuous and categorical measures) and relevant predictors.
Pre-post intervention: Participants identified as having poor adherence will be offered a structured psychoeducational program delivered via videoconference. The program includes ten group sessions led by clinical psychologists and two peer-contributor sessions, focusing on knowledge reinforcement, self-management skills, and barriers to adherence. Medication exposure levels and self-report scores will be reassessed six months post-intervention.
Setting and Population Participants will be recruited through four public hospitals in the Community of Madrid. Eligible individuals must be adults diagnosed with schizophrenia or bipolar disorder, registered in the digital patient portal, and have active antipsychotic prescriptions. Patients unable to provide informed consent or without portal access will be excluded. Consent will be obtained electronically.
The estimated eligible population is approximately 4,900 individuals. Expected questionnaire completion is ~30%, yielding ~1,640 participants for the validation component. Based on expected non-adherence rates (40-50%), approximately 650 participants are anticipated for the intervention phase.
Data Sources and Security Adherence outcomes will include digital self-report measures (Morisky-Green and Haynes-Sackett) and percentage of antipsychotic exposure obtained from the MUP over the prior six-month period. Sociodemographic and clinical characteristics (age, sex, urbanicity, comorbidities) will be extracted from the Patient Portal.
Personal identifiers will be pseudonymized and stored separately from study records. Access to data will be restricted to authorized study personnel. Digital infrastructure includes encrypted communication, firewalls, intrusion-detection systems, and periodic audit mechanisms. Data processing follows GDPR and Spanish data protection laws.
Statistical Plan Analyses will employ SPSS and R. For the validation phase, diagnostic accuracy metrics and ROC curves will be calculated. For risk-factor analysis, logistic regression (using <75% exposure as a risk threshold) and correlation analyses will be performed. For intervention evaluation, pre-post comparisons of pharmacological exposure and questionnaire scores will be conducted using appropriate paired statistical tests.
Risks and Burden The intervention consists of group psychoeducational telehealth sessions, with no known risks. Participants will not receive financial incentives. Data confidentiality and voluntary participation are ensured.
Study Relevance To our knowledge, this is the first Spanish study validating digital adherence questionnaires against real-world electronic dispensing data in patients with severe mental illness, and one of the first to integrate digital phenotyping with a peer-supported telehealth adherence program. The findings may support scalable, patient-centered models to improve adherence and long-term outcomes.
- Conditions
- Treatment Adherence and Compliance, Severe Mental Disorders, Bipolar Disorder (BD), Schizophrenia Disorder
- Being tested
- Telehealth Psychoeducational Adherence Program
- Keywords
- treatment adherence, schizophrenia, bipolar disorder, electronic health records, medication
- Medical subject headings
- Treatment Adherence and Compliance, Mental Disorders, Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Psychoeducational Adherence ProgramBehavioural
Also called ADHERA
Participants with reduced antipsychotic treatment adherence will receive a structured telehealth psychoeducational program designed to improve medication adherence. The program includes 10 weekly online group sessions led by clinical psychologists and two peer-support sessions, focusing on illness and medication education, adherence strategies, problem-solving, digital medication-management tools, and relapse-prevention skills. Participants also receive supportive written materials.
| Study group | Role | What they receive |
|---|---|---|
| Patients with adherence problems in antipsychotic treatment | Experimental | Pre-post comparison of participants identified with reduced antipsychotic medication adherence via electronic dispensing records and self-report measures will receive a structured psychoeducational adherence-support program. The intervention consists of ten online group telehealth sessions led by clinical psychologists, including two sessions with trained peer-support contributors who have lived experience of stable recovery. Sessions focus on education about illness and medication, strategies to improve adherence, problem-solving skills, digital medication management tools, and relapse-prevention planning. Participants also receive written psychoeducational materials. Duration: approximately 10 weeks, one session per week. Receives: Behavioral: Telehealth Psychoeducational Adherence Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence measured by the Morisky Medication Adherence Scale (MMAS-7)
Score on the 7-item Morisky Medication Adherence Scale (MMAS-7), range 0-7, with lower scores indicating poorer adherence.
Measured: Baseline (assessment of adherence over the previous 6 months prior to enrollment)
Antipsychotic medication exposure measured by Medication Use Profile (MUP)
Percentage of days covered (%) by antipsychotic medication over the 6 months prior to enrollment, calculated using dispensing data from the Single Prescription Module (MUP).
Measured: Baseline (medication exposure during the 6 months prior to enrollment)
Secondary outcomes (5)
Validation of digital self-reported adherence against MUP dispensing data
Correlation between digital self-reported adherence questionnaire score (specify name, scale range) and percentage of days covered (%) from MUP records.
Measured: Baseline (comparison of self-reported adherence and dispensing data for the 6 months prior to enrollment)
Correlation between sociodemographic variables and medication adherence (MMAS-7 score)
Correlation between sociodemographic variables obtained from the Patient Portal and adherence measured by MMAS-7 score (0-7 scale).
Measured: baseline
Correlation between sociodemographic variables and medication exposure (MUP %)
Correlation between sociodemographic variables and percentage of days covered (%) by antipsychotic medication based on MUP records.
Measured: Baseline (6 months prior to enrollment)
Change in medication adherence after intervention (MMAS-7 score)
Change in MMAS-7 score (range 0-7) from baseline to 6 months post-intervention.
Measured: Baseline and 6 months post-intervention
Change in percentage of days covered after intervention (MUP data)
Change in percentage of days covered (%) by antipsychotic medication from baseline (6 months prior to enrollment) to 6 months after intervention.
Measured: Baseline and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- 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
- 1,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Infanta Elena de Valdemoro, Madrid, Hospital Universitario Rey Juan Carlos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445802
- Sponsor's protocol ID
- PIC 76-2013_FJD-HIE-HRJC
- Acronym
- ADHERA
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelly JF, Hoffman L, Vilsaint C, Weiss R, Nierenberg A, Hoeppner B. Peer support for mood disorder: Characteristics and benefits from attending the Depression and Bipolar Support Alliance mutual-help organization. J Affect Disord. 2019 Aug 1;255:127-135. doi: 10.1016/j.jad.2019.05.039. Epub 2019 May 23.
PubMed 31150942Orsi JA, Malinowski FRL, Kagan S, Weingarten R, Villares CC, Bressan RA, de Oliveira WF, Andrade MCR, Gadelha A. Evaluation of Ongoing Participation of People with Schizophrenia in a Mutual Support Group as a Complementary Intervention to Outpatient Psychiatric Treatment. Psychiatr Q. 2021 Sep;92(3):1283-1296. doi: 10.1007/s11126-021-09893-z. Epub 2021 Mar 24.
PubMed 33761085Chakrabarti S. Treatment-adherence in bipolar disorder: A patient-centred approach. World J Psychiatry. 2016 Dec 22;6(4):399-409. doi: 10.5498/wjp.v6.i4.399. eCollection 2016 Dec 22.
PubMed 28078204Kim J, Ozzoude M, Nakajima S, Shah P, Caravaggio F, Iwata Y, De Luca V, Graff-Guerrero A, Gerretsen P. Insight and medication adherence in schizophrenia: An analysis of the CATIE trial. Neuropharmacology. 2020 May 15;168:107634. doi: 10.1016/j.neuropharm.2019.05.011. Epub 2019 May 9.
PubMed 31077729Loots E, Goossens E, Vanwesemael T, Morrens M, Van Rompaey B, Dilles T. Interventions to Improve Medication Adherence in Patients with Schizophrenia or Bipolar Disorders: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10213. doi: 10.3390/ijerph181910213.
PubMed 34639510Gibson S, Brand SL, Burt S, Boden ZV, Benson O. Understanding treatment non-adherence in schizophrenia and bipolar disorder: a survey of what service users do and why. BMC Psychiatry. 2013 May 29;13:153. doi: 10.1186/1471-244X-13-153.
PubMed 23714262
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Adherence Promotion Program for Severe Mental Illness: the ADHERA Study Protocol
- ClinicalTrials.gov ID
- NCT07445802
- Acronym / sponsor ID
- ADHERA / PIC 76-2013_FJD-HIE-HRJC
- Conditions
- Treatment Adherence and Compliance, Severe Mental Disorders, Bipolar Disorder (BD), Schizophrenia Disorder
- Keywords
- treatment adherence, schizophrenia, bipolar disorder, electronic health records, medication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,640 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz, Hospital Infanta Elena de Valdemoro, Madrid, Hospital Universitario Rey Juan Carlos
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Mar 2026 (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.
People living with serious mental illnesses such as schizophrenia and bipolar disorder often need long-term medication to stay well. However, many patients have difficulty taking medication regularly, which can increase the risk of relapse, hospitalization, and poorer quality of life. Traditionally, treatment adherence has been measured using self-report questionnaires, which may be influenced by memory or social desirability bias.
With the recent expansion of electronic prescription systems in Spain, it is now possible to objectively verify whether patients collect their medications from the pharmacy. This provides a new opportunity to better understand and support treatment adherence.
The ADHERA study will evaluate how well digital self-report questionnaires reflect real medication use compared with electronic dispensing records. We will also explore patient characteristics that may be associated with difficulties in medication adherence. Finally, we will test a new online psychoeducational program-including sessions led by mental health professionals and supported by peer-experience contributors-to determine whether it can help improve adherence.
Participants with schizophrenia or bipolar disorder who are registered in the hospital's digital patient portal and have active antipsychotic prescriptions will be invited to complete brief adherence questionnaires online. Individuals with signs of reduced adherence will then be invited to take part in a telehealth intervention consisting of ten group sessions, where they will receive information, support, and practical strategies to maintain their treatment plan. Medication adherence will be reassessed after six months.
If successful, this study may help improve how treatment adherence is measured in clinical practice, guide targeted interventions for individuals at higher risk of non-adherence, and provide evidence for scalable telehealth programs that can be easily implemented in other regions and medical conditions
Detailed description
This study aims to evaluate the validity of digital self-reported treatment adherence questionnaires in comparison with objective pharmacy dispensing records for antipsychotic medications, identify predictors of non-adherence, and assess the effectiveness of a telehealth intervention designed to improve adherence among adults with schizophrenia or bipolar disorder.
Study Design
The protocol incorporates three linked components:
Validation study: Sensitivity, specificity, predictive values, and ROC analysis will be used to determine the accuracy of digital adherence self-report scales compared with electronic dispensing data from the regional Single Prescription Module (MUP), considered the reference standard.
Observational study: Sociodemographic and clinical variables obtained through the Patient Portal will be analyzed to identify correlates of adherence. Logistic regression and correlation models will be applied to examine associations between treatment exposure (continuous and categorical measures) and relevant predictors.
Pre-post intervention: Participants identified as having poor adherence will be offered a structured psychoeducational program delivered via videoconference. The program includes ten group sessions led by clinical psychologists and two peer-contributor sessions, focusing on knowledge reinforcement, self-management skills, and barriers to adherence. Medication exposure levels and self-report scores will be reassessed six months post-intervention.
Setting and Population Participants will be recruited through four public hospitals in the Community of Madrid. Eligible individuals must be adults diagnosed with schizophrenia or bipolar disorder, registered in the digital patient portal, and have active antipsychotic prescriptions. Patients unable to provide informed consent or without portal access will be excluded. Consent will be obtained electronically.
The estimated eligible population is approximately 4,900 individuals. Expected questionnaire completion is ~30%, yielding ~1,640 participants for the validation component. Based on expected non-adherence rates (40-50%), approximately 650 participants are anticipated for the intervention phase.
Data Sources and Security Adherence outcomes will include digital self-report measures (Morisky-Green and Haynes-Sackett) and percentage of antipsychotic exposure obtained from the MUP over the prior six-month period. Sociodemographic and clinical characteristics (age, sex, urbanicity, comorbidities) will be extracted from the Patient Portal.
Personal identifiers will be pseudonymized and stored separately from study records. Access to data will be restricted to authorized study personnel. Digital infrastructure includes encrypted communication, firewalls, intrusion-detection systems, and periodic audit mechanisms. Data processing follows GDPR and Spanish data protection laws.
Statistical Plan Analyses will employ SPSS and R. For the validation phase, diagnostic accuracy metrics and ROC curves will be calculated. For risk-factor analysis, logistic regression (using <75% exposure as a risk threshold) and correlation analyses will be performed. For intervention evaluation, pre-post comparisons of pharmacological exposure and questionnaire scores will be conducted using appropriate paired statistical tests.
Risks and Burden The intervention consists of group psychoeducational telehealth sessions, with no known risks. Participants will not receive financial incentives. Data confidentiality and voluntary participation are ensured.
Study Relevance To our knowledge, this is the first Spanish study validating digital adherence questionnaires against real-world electronic dispensing data in patients with severe mental illness, and one of the first to integrate digital phenotyping with a peer-supported telehealth adherence program. The findings may support scalable, patient-centered models to improve adherence and long-term outcomes.
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 |
|---|---|---|
| Patients with adherence problems in antipsychotic treatment | Experimental | Behavioral: Telehealth Psychoeducational Adherence ProgramPre-post comparison of participants identified with reduced antipsychotic medication adherence via electronic dispensing records and self-report measures will receive a structured psychoeducational adherence-support program. The intervention consists of ten online group telehealth sessions led by clinical psychologists, including two sessions with trained peer-support contributors who have lived experience of stable recovery. Sessions focus on education about illness and medication, strategies to improve adherence, problem-solving skills, digital medication management tools, and relapse-prevention planning. Participants also receive written psychoeducational materials. Duration: approximately 10 weeks, one session per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis established using ICD-11 clinical criteria [15].
- Aged 18 years or older.
- Registered on the Patient Portal.
- With an active prescription for antipsychotic drugs in the MUP (Medication Use Profile).
Key exclusion criteria (4 listed)
- Aged under 18 years old.
- Unable to provide consent for medical or legal reasons.
- Not registered on the Patient Portal.
- No active prescription for antipsychotic drugs in the MUP.
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 |
|---|---|---|
| Telehealth Psychoeducational Adherence ProgramAlso: ADHERAParticipants with reduced antipsychotic treatment adherence will receive a structured telehealth psychoeducational program designed to improve medication adherence. The program includes 10 weekly online group sessions led by clinical psychologists and two peer-support sessions, focusing on illness and medication education, adherence strategies, problem-solving, digital medication-management tools, and relapse-prevention skills. Participants also receive supportive written materials. | Behavioural | Patients with adherence problems in antipsychotic treatment |
Primary outcome
Medication adherence measured by the Morisky Medication Adherence Scale (MMAS-7)
Time frame: Baseline (assessment of adherence over the previous 6 months prior to enrollment)
Score on the 7-item Morisky Medication Adherence Scale (MMAS-7), range 0-7, with lower scores indicating poorer adherence.
Antipsychotic medication exposure measured by Medication Use Profile (MUP)
Time frame: Baseline (medication exposure during the 6 months prior to enrollment)
Percentage of days covered (%) by antipsychotic medication over the 6 months prior to enrollment, calculated using dispensing data from the Single Prescription Module (MUP).
5 secondary outcomes
Validation of digital self-reported adherence against MUP dispensing data
Time frame: Baseline (comparison of self-reported adherence and dispensing data for the 6 months prior to enrollment)
Correlation between sociodemographic variables and medication adherence (MMAS-7 score)
Time frame: baseline
Correlation between sociodemographic variables and medication exposure (MUP %)
Time frame: Baseline (6 months prior to enrollment)
Change in medication adherence after intervention (MMAS-7 score)
Time frame: Baseline and 6 months post-intervention
Change in percentage of days covered after intervention (MUP data)
Time frame: Baseline and 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 31150942Kelly JF, Hoffman L, Vilsaint C, Weiss R, Nierenberg A, Hoeppner B. Peer support for mood disorder: Characteristics and benefits from attending the Depression and Bipolar Support Alliance mutual-help organization. J Affect Disord. 2019 Aug 1;255:127-135. doi: 10.1016/j.jad.2019.05.039. Epub 2019 May 23.
- Results publication: PubMed 33761085Orsi JA, Malinowski FRL, Kagan S, Weingarten R, Villares CC, Bressan RA, de Oliveira WF, Andrade MCR, Gadelha A. Evaluation of Ongoing Participation of People with Schizophrenia in a Mutual Support Group as a Complementary Intervention to Outpatient Psychiatric Treatment. Psychiatr Q. 2021 Sep;92(3):1283-1296. doi: 10.1007/s11126-021-09893-z. Epub 2021 Mar 24.
- Results publication: PubMed 28078204Chakrabarti S. Treatment-adherence in bipolar disorder: A patient-centred approach. World J Psychiatry. 2016 Dec 22;6(4):399-409. doi: 10.5498/wjp.v6.i4.399. eCollection 2016 Dec 22.
- Results publication: PubMed 31077729Kim J, Ozzoude M, Nakajima S, Shah P, Caravaggio F, Iwata Y, De Luca V, Graff-Guerrero A, Gerretsen P. Insight and medication adherence in schizophrenia: An analysis of the CATIE trial. Neuropharmacology. 2020 May 15;168:107634. doi: 10.1016/j.neuropharm.2019.05.011. Epub 2019 May 9.
- Results publication: PubMed 34639510Loots E, Goossens E, Vanwesemael T, Morrens M, Van Rompaey B, Dilles T. Interventions to Improve Medication Adherence in Patients with Schizophrenia or Bipolar Disorders: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 28;18(19):10213. doi: 10.3390/ijerph181910213.
- Results publication: PubMed 23714262Gibson S, Brand SL, Burt S, Boden ZV, Benson O. Understanding treatment non-adherence in schizophrenia and bipolar disorder: a survey of what service users do and why. BMC Psychiatry. 2013 May 29;13:153. doi: 10.1186/1471-244X-13-153.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Psychoeducational Adherence Program in people with Treatment Adherence and Compliance and Severe Mental Disorders, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz.
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 4 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: opening soon, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 measured by the Morisky Medication Adherence Scale (MMAS-7) (time frame: Baseline (assessment of adherence over the previous 6 months prior to enrollment)). 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?
On the ClinicalTrials.gov record for NCT07445802, which also lists 6 linked publications.
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 3 Mar 2026.