Psychotic Disorders, Schizo Affective Disorder, Schizophrenia
Conditions
Keywords
Digital Health, Mobile Health, Smartphone
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALA4i Intervention
6 months of the provision of A4i on the individual's own device.
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants will be adults, 18 years of age or older, with a chart diagnosis of a DSM-5 schizophrenia spectrum illness confirmed by a structured diagnostic interview (SCID-5)40. 2. All participants will be engaged in outpatient psychiatric treatment. 3. Proficiency in English. 4. Own and use an Android or iOS smartphone.
Exclusion criteria
1. Lack of capacity with no identified substitute decision maker. 2. Intellectual disability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Through recruitment process an average of 1 week during a 21 month recruitment period. | Number of individuals successfully recruited into the trial with a target of 91. |
| Retention | 6 months per participant in a 27 month period. | Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited. |
| App Interactions | Up to 6 months. | Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant. |
| Incidence of Treatment-Emergent Adverse Events | Up to 6 months. | 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. |
| App Likes | Up to 6 months. | Total number of posts liked for each participant will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BSI: Psychiatric Symptoms | Baseline-6 months. | General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory. Range 0-212. Lower values are better. |
| BARS: Medication Adherence | Baseline-6 months. | 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. |
| STAR-P: Patient Relationship With Clinician | Baseline-6 months. | 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. |
| QLS: Heinrichs-Carpenter Quality of Life Scale | Baseline-6 months. | 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). |
| PANSS: Schizophrenia Symptoms | Baseline-6 months. | 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). |
| GAIN-SS | Baseline-6 months. | 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). |
| MOS: Treatment Adherence - General | Baseline-6 months. | 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). |
| Appointment Attendance | Baseline-6 months. | 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. |
| STAR-C: Clinician Relationship With Patient | Baseline - 6 months | 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). |
| SUH - Patients | baseline - 6 months | 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. |
| SUH - Clinicians | Baseline - 6 months | 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. |
Countries
Canada
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.8 years STANDARD_DEVIATION 10.9 |
| Diagnosis Other Specified Psychotic Disorder | 17 Participants |
| Diagnosis Schizoaffective Disorder | 13 Participants |
| Diagnosis Schizophrenia | 25 Participants |
| Diagnosis Schizophreniform | 6 Participants |
| Education Graduate School | 5 Participants |
| Education High School or Below | 13 Participants |
| Education University | 23 Participants |
| Employment Employed (incl. Self-Employed) | 15 Participants |
| Employment Other | 2 Participants |
| Employment Student | 24 Participants |
| Employment Unemployed | 17 Participants |
| Employment Volunteer Work/Unpaid | 3 Participants |
| Race/Ethnicity, Customized Afro-Caribbean or African Origin | 18 Participants |
| Race/Ethnicity, Customized Indigenous | 4 Participants |
| Race/Ethnicity, Customized Other | 33 Participants |
| Race/Ethnicity, Customized White European Origin | 16 Participants |
| Region of Enrollment Canada Born Elsewhere | 12 Participants |
| Region of Enrollment Canada Born in Canada | 31 Participants |
| Relation Status Married/In a Relationship/Cohabitating with a Partner | 5 Participants |
| Relation Status Single/Separated/Divorced/Widowed | 73 Participants |
| Sex/Gender, Customized man | 54 Participants |
| Sex/Gender, Customized non-binary | 2 Participants |
| Sex/Gender, Customized woman | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 48 |
| other Total, other adverse events | 0 / 43 | 0 / 48 |
| serious Total, serious adverse events | 0 / 43 | 0 / 48 |
Outcome results
None listed