Mental Health Issue Clinical Trial
Official title:
Pilot Study on the Clinical Utility of the Tulsa Life Chart: A Graphical Representation of Patient Life History
Verified date | November 2023 |
Source | Laureate Institute for Brain Research, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The proposed study aims to examine the usability, utility, and feasibility of the Tulsa Life Chart (TLC) in a sample of patients seeking mental health treatment and their healthcare providers. The TLC is an interactive, web-based application used to create a graphical interface for visualizing a patient's life history.
Status | Enrolling by invitation |
Enrollment | 130 |
Est. completion date | August 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility | Inclusion Criteria: Treatment Seekers Inclusion Criteria: 1. Actively seeking mental health treatment at Laureate Psychiatric Clinic and Hospital 2. Provision of informed consent or if <18 assent and parental consent 3. Age 15 to 65 years 4. Necessary resources to engage in a technology-based intervention 5. English proficiency 6. Willingness to grant access to medical records HCPs Inclusion Criteria: 1. Employed at Laureate Psychiatric Clinic and Hospital in a patient care role 2. Informed consent 3. English proficiency 4. Access to resources to engage in technology-based intervention Exclusion Criteria: Treatment Seekers Exclusion Criteria: 1. Active suicidal ideation with plan or intent 2. No access to resources to participate in a technology-based intervention 3. Completed more than 2 sessions of therapy with their current provider prior to enrollment in the study 4. Not proficient in English HCPs Exclusion Criteria: 1. No access to resources to participate in a technology-based intervention 2. Not proficient in English |
Country | Name | City | State |
---|---|---|---|
United States | Laureate Institute for Brain Research | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Laureate Institute for Brain Research, Inc. |
United States,
Aupperle RL, Paulus MP, Kuplicki R, Touthang J, Victor T, Yeh HW; Tulsa 1000 Investigators; Khalsa SS. Web-Based Graphic Representation of the Life Course of Mental Health: Cross-Sectional Study Across the Spectrum of Mood, Anxiety, Eating, and Substance Use Disorders. JMIR Ment Health. 2020 Jan 28;7(1):e16919. doi: 10.2196/16919. — View Citation
Born C, Amann BL, Grunze H, Post RM, Scharer L. Saving time and money: a validation of the self ratings on the prospective NIMH Life-Chart Method (NIMH-LCM). BMC Psychiatry. 2014 May 7;14:130. doi: 10.1186/1471-244X-14-130. — View Citation
Denicoff KD, Ali SO, Sollinger AB, Smith-Jackson EE, Leverich GS, Post RM. Utility of the daily prospective National Institute of Mental Health Life-Chart Method (NIMH-LCM-p) ratings in clinical trials of bipolar disorder. Depress Anxiety. 2002;15(1):1-9. doi: 10.1002/da.1078. — View Citation
Manderscheid RW, Ryff CD, Freeman EJ, McKnight-Eily LR, Dhingra S, Strine TW. Evolving definitions of mental illness and wellness. Prev Chronic Dis. 2010 Jan;7(1):A19. Epub 2009 Dec 15. — View Citation
Post RM, Roy-Byrne PP, Uhde TW. Graphic representation of the life course of illness in patients with affective disorder. Am J Psychiatry. 1988 Jul;145(7):844-8. doi: 10.1176/ajp.145.7.844. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient) | Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | Change in perception of usefulness | Change in mHealth App Usability Questionnaire (MAUQ) score from first assessment time point to second assessment time point. Scores on the MAUQ range from 18 to 126. Higher scores indicate greater usability. | Change from baseline to the post-treatment timepoint, approximately 4 - 12 weeks after baseline | |
Other | mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient) | Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient) | Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient) | Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | mHealth App mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | Utility Questionnaire (Patient) | This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement. Scores range from 6 to 28 with higher scores indicating greater utility for patients. | Baseline assessment | |
Other | Utility Questionnaire (Healthcare Professional) | This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart. Domains include ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations. Scores range from 7 to 35 with higher scores indicating greater utility for healthcare professionals. | Baseline assessment | |
Other | Utility Questionnaire (Patient) | This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks treatment seekers questions pertaining to their experience using the Tulsa Life Chart including: ease of understanding and impact of completing the Tulsa Life Chart on remembering life events, understanding of mental health patterns, communication with their provider, and motivation for treatment engagement. Scores range from 5 to 23 with higher scores indicating greater utility for patients. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | Utility Questionnaire (Healthcare Professional) | This measure was created for the purpose of the current study to measure how useful the assessment tool was in multiple domains. This measure asks healthcare professionals questions pertaining to their experience viewing their patient's Tulsa Life Chart. Domains include impact on therapy; ease of understanding the chart; usefulness in diagnosing their patient; and impact on understanding patient's psychosocial history, understanding patterns in their patient's mental health, and facilitating conversations. Scores range from 8 to 35 with higher scores indicating greater utility for healthcare professionals. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | Likelihood of recommending the Tulsa Life Chart to other patients (Patient) | One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart. "How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart. | Baseline assessment | |
Other | Likelihood of recommending the Tulsa Life Chart to other healthcare professionals (Healthcare Professional) | One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals. "Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart. | Baseline assessment | |
Other | Likelihood of recommending the Tulsa Life Chart to other patients (Patient) | One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart. "How likely are you to recommend the Tulsa Life Chart to someone else who may be experiencing mental health symptoms?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Other | Likelihood of recommending (Healthcare Professional) | One question will be used to assess the patient's likelihood of recommending the Tulsa Life Chart to other healthcare professionals. "Based on this experience, how likely are you to recommend the Tulsa Life Chart to other providers?" Scores range from 1 to 5, with higher scores indicating greater likelihood of recommending to the chart. | Assessment two - on average 4 to 12 weeks after baseline assessment | |
Primary | mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Patient) | Validated self-report survey in which participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability. | Baseline assessment | |
Primary | mHealth App Usability Questionnaire (MAUQ) Total Usability Score (Healthcare Professional) | Validated self-report survey in which healthcare professional participants indicate how usable the assessment tool was, with scores ranging from 18 to 126. Higher scores indicate greater usability. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Patient) | Subscale of a validated self-report survey in which patient participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Ease of Use Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professional participants report how easy the assessment tool was to use. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Patient) | Subscale of a validated self-report survey in which patients rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Interface and Satisfaction Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professionals rate their satisfaction with the assessment tool and the interface of the tool. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Patient) | Subscale of a validated self-report survey in which patients rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness. | Baseline assessment | |
Secondary | mHealth App Usability Questionnaire (MAUQ) - Usefulness Subscale (Healthcare Professional) | Subscale of a validated self-report survey in which healthcare professionals rate the usefulness of the assessment tool. Usefulness scores range from 6 to 42 with higher scores indicating greater usefulness. | Baseline assessment | |
Secondary | Time spent to complete the Tulsa Life Chart (Patient) | Treatment seekers self-report of time to complete the TLC and embedded time count from the TLC application. | Baseline assessment | |
Secondary | Time spent to reviewing the Tulsa Life Chart (Healthcare Professional) | Healthcare professionals' self-report of time spent reviewing the TLC and embedded time count from the TLC application. | Baseline assessment |
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