Implementing a low-cost web-based clinical trial management system for community studies: a case study

Geyer, John R.; Myers, Kathleen; Stoep, Ann Vander; McCarty, Carolyn A.; Palmer, Nancy; DeSalvo, Amy

doi:10.1177/1740774511416384

Cited by 23 publications

(21 citation statements)

References 11 publications

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“…Caregivers completed the assessments remotely from personal computers with data entered directly into the outcomes database (Geyer et al, 2011) at baseline, and 4, 10, 19, and 25 weeks post-randomization. The 25-week assessment was timed for completion halfway between the end of the CATTS service delivery (22 weeks) and return to their PCP’s care (27 weeks).…”

Section: Methodsmentioning

confidence: 99%

The Children’s Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes

Stoep

McCarty

Zhou

et al. 2016

J Abnorm Child Psychol

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Section: Methodsmentioning

confidence: 99%

The Children’s Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes

Stoep

McCarty

Zhou

et al. 2016

J Abnorm Child Psychol

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“…51 Questionnaires were stored in a database until requested by a participant. The WebQ software was used to build the questionnaire and to display it in the participant’s browser.…”

Section: Challenges In Conducting a Clinical Trial In Multiple Under-mentioning

confidence: 99%

Methodology for conducting the Children’s Attention-deficit Hyperactivity Disorder Telemental Health Treatment Study in multiple underserved communities

Stoep

Myers

2013

Clinical Trials

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Background Children who live in non-metropolitan communities are underserved by evidence-based mental health care and underrepresented in clinical trials of mental health services. Telemental Health (TMH), the use of videoteleconferencing (VTC) to provide care that is usually delivered in person, shows promise for helping to rectify these service disparities. Purpose The Children’s ADHD Telemental Health Treatment Study (CATTS) is a randomized controlled trial designed to test the effectiveness of TMH in providing treatment to children diagnosed with attention-deficit hyperactivity disorder (ADHD) who are living in underserved communities. In this paper we describe the methodologies we developed for the trial and lessons learned. Methods Children ages 5.5-12 years of age with ADHD were referred to CATTS by their primary care physicians (PCP’s). The test intervention group (Group A) received six telepsychiatry sessions followed by in-person caregiver behavioral training delivered by a local therapist who was trained and supervised remotely. A secure website was used to support decision-making by the telepsychiatrists, to facilitate real-time collaboration between the telepsychiatrists and community therapists, and communication with the PCP’s. The control group (Group B) received a single telepsychiatry consultation followed by treatment with their PCP’s who implemented the telepsychiatrists’ recommendations at their discretion. Caregivers completed five sets of questionnaires about children’s symptoms and functioning and their own levels of distress. Older children (aged 10-12 years) completed questionnaires about their symptoms and functioning. Teachers completed ADHD rating scales. Questionnaires were completed online through a secure portal from personal computers. Results Eighty-eight PCP’s in seven communities referred the 223 children who participated in the trial. Attrition was low (3%). Children in Group A completed an average of 5.3 of 6 scheduled sessions; 96% of children in Group B completed their telepsychiatry consultation. Parents in both groups completed an average of 4.8 of 5 assessments. Telepsychiatrists and therapists showed high adherence to treatment protocols. Lessons Learned TMH proved to be a viable means of providing evidence-based pharmacological services to children and of training local therapists in evidence-based caregiver behavioral management. Recruitment was enhanced by offering the control group a telepsychiatry consultation. To meet recruitment targets across multiple dispersed sites, we developed community-specific strategies. A dedicated scheduler was a critical staff role to coordinate the multiple sites, sessions, and clinicians. Trial implementation was easier with sites that shared an electronic medical record system with our research hub. Conclusions The CATTS study used methods and procedures to optimize inclusion of children living in multiple dispersed and underserved areas. These experiences should advance the development of technologies needed to recruit ...

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“…An asynchronous administrative portal was developed with a Web-based tool called Catalyst Common View. 41,53 The therapists and the research hub communicated through a secure upload area for intervention materials and an embedded Google calendar for scheduled appointments. To support therapists' coordination of clinical tasks with the telepsychiatrists, we developed a ''near-real-time'' Webbased registry and data management system.…”

Section: Supporting Technologies To Assist Therapists In Spoke Sitesmentioning

confidence: 99%

“…[37][38][39][40] Caregivers completed their assessments online through a portal that transmitted data directly into the outcomes database. 41 Secondary outcomes included measures of functional impairment. The Columbia Impairment Scale-Parent Version (CIS-P) is a 14-item measure scale that assesses functional impairment across domains of interpersonal relationships, psychopathology, schoolwork or job, and use of leisure time.…”

Section: Outcomes and Study Measuresmentioning

confidence: 99%

Teletherapy Delivery of Caregiver Behavior Training for Children with Attention-Deficit Hyperactivity Disorder

Tse

McCarty

Stoep

et al. 2015

Telemedicine and e-Health

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Background: Preliminary studies suggest that videoteleconferencing (VTC) may be an effective means to deliver behavioral interventions to families. Subjects consisted of a subsample of children (n = 37) and caregivers who participated in the Children's Attention-Deficit Hyperactivity Disorder (ADHD) Telemental Health Treatment Study (CATTS) (n = 223), a randomized trial testing the effectiveness of delivering treatments for ADHD to families residing in their home communities using distant technologies. Families randomized to the CATTS intervention arm received pharmacotherapy and caregiver behavior training. Materials and Methods: Thirty-seven families from the CATTS intervention arm participated. All families received pharmacotherapy through VTC. Twelve families received the caregiver behavior training through VTC, or teletherapy, and 25 received the intervention in-person. We assessed children's outcomes at 25 weeks with the Vanderbilt ADHD Parent Rating Scale and the Columbia Impairment Scale. We assessed caregivers' outcomes using measures of distress in caring for a child with ADHD, including depression, stress, strain, and empowerment. We used analysis of covariance to assess outcomes from baseline to 25 weeks. Results: Families in the two conditions showed comparable attendance at sessions and satisfaction with their care. Caregivers in both conditions reported comparable outcomes for their children's ADHD-related behaviors and functioning, but caregivers in the teletherapy group did not report improvement in their own distress. Conclusions: Findings support the feasibility, acceptability, and effectiveness of treating children with ADHD through teletherapy. Future work should investigate how teletherapy may improve caregivers' distress. Teletherapy is a promising modality for delivering behavioral interventions for children with ADHD.

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Implementing a low-cost web-based clinical trial management system for community studies: a case study

Cited by 23 publications

References 11 publications

The Children’s Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes

The Children’s Attention-Deficit Hyperactivity Disorder Telemental Health Treatment Study: Caregiver Outcomes

Methodology for conducting the Children’s Attention-deficit Hyperactivity Disorder Telemental Health Treatment Study in multiple underserved communities

Teletherapy Delivery of Caregiver Behavior Training for Children with Attention-Deficit Hyperactivity Disorder

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