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The effective treatment of schizophrenia is very challenging due to a number of factors.
These include issues such as poor engagement with treatment plans and care providers, limited contacts with providers due to under-resourced health services, and the challenges inherent to schizophrenia symptoms. The outcomes of these problems include frequent, lengthy, and costly hospital readmissions, low quality of life, high levels of distress, and difficulties engaging in valued community roles. Digital Health technologies are a promising model to help address these problems. They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses. In this study, the feasibility of one such technology that is in development will be tested: App4Independence (A4i). A4i provides customized coping prompts, peer-peer networking, and a portal that facilitates better provider engagement. This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief, infrequent, and rely on in the moment recall and self-advocacy by patients. These findings will lay the groundwork for a larger program of research and software development that will (i) validate the technology across multiple sites and, (ii) catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource.
Problem Statement: Among schizophrenia-spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Across healthcare domains, digital health is a rapidly growing area due to its potential reach, accessibility, low cost, and implications for the use of data to customize treatments and identify risk trajectories. Despite this promise and for reasons that are not entirely clear, the development and study of digital health strategies for more severe mental health conditions such as schizophrenia is much less developed than other domains of healthcare.
Objective: This feasibility trial will examine a digital health platform designed to enhance illness self-management and treatment engagement for individuals with schizophrenia.
Technology: The investigators and collaborators have developed and piloted a digital technology called App4Independence (A4i). This platform was designed to (i) help prevent social isolation through behavioral activation prompts and peer-peer strategy sharing, (ii) enhance coping with schizophrenia symptoms through functions that draw on evidence-based strategies (e.g., texted tips derived from cognitive and behavioral therapies) and provide a novel technology that assists with the identification of auditory hallucinations, (iii) enhance treatment adherence through scheduling, text and reminder functions, (iv) track level of wellness/risk and progress on personal goals through both active (self-ratings) and passive (sleep monitoring proxy) metrics, and (v) facilitate communications with care providers through a provider dashboard summarizing platform-collected data gathered between appointments.
Partners: This study builds on a partnership between the Centre for Addiction and Mental Health (research capability, mental health service and associated expertise, access to patient populations) and MEMOTEXT, a health technology company with a track record of success in digital health approaches across multiple health conditions and care contexts.
Study Design: This single blind, randomized controlled trial examines the feasibility of A4i. Feasibility metrics include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, study participants will be randomized to either treatment or control conditions, with pre-post outcomes measured over a 6-month period.
Implications: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field - how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. These findings will lay the groundwork for larger trials assessing the impacts of A4i on hospital readmission and functioning - providing essential evidence for commercialization and expanded access to this tool. This work is at the forefront of international efforts to explore and validate digital health approaches for schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A4i Intervention | Experimental | App4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes:
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| Treatment As Usual | No Intervention | Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A4i Intervention | Behavioral | 6 months of the provision of A4i on the individual's own device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Number of individuals successfully recruited into the trial with a target of 91. | Through recruitment process an average of 1 week during a 21 month recruitment period. |
| Retention | Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited. | 6 months per participant in a 27 month period. |
| App Interactions | Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant. | Up to 6 months. |
| Incidence of Treatment-Emergent Adverse Events | Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use. | Up to 6 months. |
| App Likes | Total number of posts liked for each participant will be collected. | Up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| BSI: Psychiatric Symptoms | General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory. Range 0-212. Lower values are better. | Baseline-6 months. |
| BARS: Medication Adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M6R2C4 | Canada |
The plan is to share study metrics with participant identifiers removed (e.g., age, gender, ethnicity".
These data will be provided after the publication of study results.
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| ID | Title | Description |
|---|---|---|
| FG000 | A4i Intervention | App4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes:
A4i Intervention: 6 months of the provision of A4i on the individual's own device. |
| FG001 | Treatment As Usual | Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | A4i Intervention | App4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes:
A4i Intervention: 6 months of the provision of A4i on the individual's own device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment | Number of individuals successfully recruited into the trial with a target of 91. | Posted | Count of Participants | Participants | Through recruitment process an average of 1 week during a 21 month recruitment period. |
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Up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A4i Intervention | App4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes:
A4i Intervention: 6 months of the provision of A4i on the individual's own device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sean Kidd | Centre for Addiction and Mental Health | 416-535-8501 | 36295 | Sean.Kidd@camh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2022 | Nov 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Blocked randomization, stratified by gender, will be employed to ensure balance in sample size between treatment and control groups and gender representation. Stratification by study site (CAMH versus community agency) will also be undertaken to determine feasibility questions that may differ as a function of same. REDCap will be employed and will allocate based on the computer-generated randomization list. Allocation concealment will be achieved since the person making the assignment will have no awareness or control over the randomization schedule.
Medication adherence will be measured using the 4-item Brief Adherence Rating Scale with responses obtained by both providers and participants to assess medication adherence. There are two indicators, both are pre-post changes, "days not taken" and "days taken less", and both are not scored as a percentage.
The change scores for taking medication less (days taken less) and medication not taken (days not taken) were calculated as the difference from their 6 month score minus their baseline score. An value of "better" was assigned when the change score is > 0, value of "no change" was assigned when the change score is = 0, and a value of "worse" value was assigned when the change score is < 0.
| Baseline-6 months. |
| STAR-P: Patient Relationship With Clinician | Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48. | Baseline-6 months. |
| QLS: Heinrichs-Carpenter Quality of Life Scale | The Heinrichs-Carpenter Quality of Life Scale, has 21 items, is well validated for schizophrenia, and captures sense of purpose, motivation, emotional and social interaction, role functioning, and engagement in regular activities. Higher values are better. Range 0-126. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Baseline-6 months. |
| PANSS: Schizophrenia Symptoms | Schizophrenia-specific symptomatology will be assessed with the Positive and Negative Syndrome Scale. Lower values are better. Range 30-210. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Baseline-6 months. |
| GAIN-SS | Global Appraisal of Individual Needs- Short Screener (GAIN-SS) - Instrument used for screening possible internalizing or externalizing psychiatric disorders, substance use disorders, or crime and violence problems. Lower values are better. Range 0-20. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Baseline-6 months. |
| MOS: Treatment Adherence - General | The 5-item, 6-point likert scale Medical Outcomes Study general adherence scale to capture broader adherence to treatment recommendations (again triangulated with provider responses). Higher values are better. Range 5-26. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Baseline-6 months. |
| Appointment Attendance | The average rate of scheduled appointments attended through EMR audit at CAMH or provider report at non-CAMH sites. No show vs. attending rates for both arms do not add up to 100% since an additional measure of cancelled rates was measured in the RCT. However, this variable was excluded from analysis since in the client's medical records it is unclear whether the clinician or client cancelled the appointment. | Baseline-6 months. |
| STAR-C: Clinician Relationship With Patient | Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Baseline - 6 months |
| SUH - Patients | Service Use History measure to assess past month service use history. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months. | baseline - 6 months |
| SUH - Clinicians | Service Use History measure to assess past month service use history of patient participant. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services for the patient participant Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service for the patient participant There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months. | Baseline - 6 months |
| BG001 | Treatment As Usual | Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Relation Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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| Participants |
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| Primary | Retention | Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited. | Posted | Count of Participants | Participants | 6 months per participant in a 27 month period. |
|
|
|
| Primary | App Interactions | Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant. | 0 individuals from the TAU group were analyzed since they did not have access to the mobile A4i intervention | Posted | Mean | Standard Deviation | interactions | Up to 6 months. |
|
|
|
| Primary | Incidence of Treatment-Emergent Adverse Events | Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use. | Posted | Count of Participants | Participants | Up to 6 months. |
|
|
|
| Secondary | BSI: Psychiatric Symptoms | General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory. Range 0-212. Lower values are better. | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | BARS: Medication Adherence | Medication adherence will be measured using the 4-item Brief Adherence Rating Scale with responses obtained by both providers and participants to assess medication adherence. There are two indicators, both are pre-post changes, "days not taken" and "days taken less", and both are not scored as a percentage. The change scores for taking medication less (days taken less) and medication not taken (days not taken) were calculated as the difference from their 6 month score minus their baseline score. An value of "better" was assigned when the change score is > 0, value of "no change" was assigned when the change score is = 0, and a value of "worse" value was assigned when the change score is < 0. | Posted | Number | participants | Baseline-6 months. |
|
|
|
| Secondary | STAR-P: Patient Relationship With Clinician | Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48. | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | QLS: Heinrichs-Carpenter Quality of Life Scale | The Heinrichs-Carpenter Quality of Life Scale, has 21 items, is well validated for schizophrenia, and captures sense of purpose, motivation, emotional and social interaction, role functioning, and engagement in regular activities. Higher values are better. Range 0-126. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | PANSS: Schizophrenia Symptoms | Schizophrenia-specific symptomatology will be assessed with the Positive and Negative Syndrome Scale. Lower values are better. Range 30-210. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | GAIN-SS | Global Appraisal of Individual Needs- Short Screener (GAIN-SS) - Instrument used for screening possible internalizing or externalizing psychiatric disorders, substance use disorders, or crime and violence problems. Lower values are better. Range 0-20. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | MOS: Treatment Adherence - General | The 5-item, 6-point likert scale Medical Outcomes Study general adherence scale to capture broader adherence to treatment recommendations (again triangulated with provider responses). Higher values are better. Range 5-26. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Posted | Mean | Standard Deviation | score on a scale | Baseline-6 months. |
|
|
|
| Secondary | Appointment Attendance | The average rate of scheduled appointments attended through EMR audit at CAMH or provider report at non-CAMH sites. No show vs. attending rates for both arms do not add up to 100% since an additional measure of cancelled rates was measured in the RCT. However, this variable was excluded from analysis since in the client's medical records it is unclear whether the clinician or client cancelled the appointment. | No show vs. attending rates for both arms do not add up to 100% since an additional measure of cancelled rates was measured in the RCT. However, this variable was excluded from analysis since in the client's medical records it is unclear whether the clinician or client cancelled the appointment. | Posted | Mean | Standard Deviation | percentage of scheduled visits | Baseline-6 months. |
|
|
|
| Secondary | STAR-C: Clinician Relationship With Patient | Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48. Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre). | Only a subset of the participants had their clinician participate in the study with them. | Posted | Mean | Standard Deviation | score on a scale | Baseline - 6 months |
|
|
|
| Secondary | SUH - Patients | Service Use History measure to assess past month service use history. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months. | Posted | Mean | Standard Deviation | service use visits | baseline - 6 months |
|
|
|
| Secondary | SUH - Clinicians | Service Use History measure to assess past month service use history of patient participant. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services for the patient participant Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service for the patient participant There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months. | Only a subset of the participants had a clinician participate with them. | Posted | Mean | Standard Deviation | service use visits | Baseline - 6 months |
|
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| Primary | App Likes | Total number of posts liked for each participant will be collected. | 0 individuals from the TAU group were analyzed since they did not have access to the mobile A4i intervention | Posted | Mean | Standard Deviation | app likes | Up to 6 months. |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Treatment As Usual | Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. | 0 | 48 | 0 | 48 | 0 | 48 |
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| Pre-Post Change |
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| NA (Days not taken) |
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| No Change (Days taken less) |
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| Worse (Days taken less) |
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| Better (Days taken less) |
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| NA (Days taken less) |
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| Pre-Post Change |
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| Pre-Post Change |
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| Pre-Post Change |
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| Pre-Post Change |
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| Pre-Post Change |
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| Pre-Post Intervention |
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| Mental Health Appointment Baseline |
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| Mental Health Appointment Follow-up |
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| Mental Health Appointments Baseline |
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| Mental Health Appointments Follow-up |
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