跳至主要内容
临床试验/NCT04526067
NCT04526067已完成不适用

In-person vs. Remote Wellness Support (Study Sub-title: Remote Cognitive Adaptation Training to Improve Medication Follow Through in Managed Care (R-CAT))

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment

研究概览

简要总结

The study team will use components of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to compare Cognitive Adaptation Training (CAT) to Remotely delivered Cognitive Adaptation Training (R-CAT) 1-9 within a managed care organization (MCO), targeting members with serious mental illness (SMI) needing assistance with the regular taking of medication.

详细描述

Individuals choosing or assigned to R-CAT will continue treatment as usual with their health care team and R-CAT will be added. R-CAT is a remotely delivered version of CAT focused on medication adherence using a series of manual-driven compensatory strategies and environmental supports (signs, checklists, electronic cueing devices) based upon a streamlined assessment of executive function impairment and barriers to habit formation including forgetfulness, difficulties in problem-solving, disorganization, apathy or amotivation, disinhibition. and home environment. Initial R-CAT goals are to 1) ensure that medications listed as prescribed are available 2) to assess current cognitive, behavioral and environmental facilitators and barriers to habit-formation 3) to set up customized CAT supports to address the barriers and use facilitators to build habits to take medication. Rare home visits may occur if issues cannot be resolved remotely. Based upon the pilot, the study team don't anticipate any more than 5-10% of individuals to need face-to-face visits. No one had home visits as part of the pilot intervention. A structured R-CAT treatment note with places for pictures of CAT interventions is used for home visits. Support and reminder calls use a brief checklist modified from the Healthy Habits Program to address issues in use of supports, placement of supports and habit formation. Examples of CAT interventions to promote taking medication regularly appear above. All home visits and phone calls will be audio-taped (with consent) for quality assurance.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Those with no preference for CAT or R-CAT will be Randomized, 1:1 done by statistician who has no patient contact through a random allocation program. If blinds are broken accidentally, new raters can be assigned, but blinds are kept by having raters and pill counters unaware of treatment group or study design.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to give informed consent.
  • Between the ages of 18 and
  • Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
  • Receiving treatment with oral psychiatric medications.
  • Have had a hospitalization or emergency department visit in the past year
  • Have a Medication Possession Ratio (MPR) based upon electronic refill data below 80% at least 1 of the past 4 quarters with at least 1 psychiatric medication
  • Responsible for taking their own medications
  • Report on telephone prescreen call with researcher team that they have missed at least 2 doses of medication in the past 3 weeks, that they are willing to take medication and would like remote assistance to take medication more regularly
  • Report on telephone prescreen call with research team that they have a stable living environment (individual apartment, family home, board and care facility) within the last three months and no plans to move in the next year
  • Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
  • Have a working smart phone
  • Able to understand and complete rating scales and assessments.
  • Agree to home visits for intervention and to count pills and conduct assessments

排除标准

  • Substance dependence within the past 2 months
  • Currently being treated by an ACT team
  • Documented history of violence or threatening behavior on initial assessment
  • Receive home visits to assist with medication adherence
  • Unable to complete baseline assessments

结局指标

主要结局

Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment

时间窗: Baseline to 6 months

Proportion of subjects who dropped out of treatment

Medication Adherence

时间窗: Baseline to 6 months

Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed.

Functional Outcome

时间窗: Baseline to 6 months note that repeated measures analysis was also used

Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. The value reported is the the 6 month value minus the baseline value\>

次要结局

  • Symptomatology(Baseline to 6 months)
  • Self-Report Habit Index (SRHI)(Baseline to 6 months (note that repeated measures analysis examined change over time as well.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Velligan

Director, Division of Community Recovery, Research and Training

The University of Texas Health Science Center at San Antonio

研究点 (2)

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