In-person vs. Remote Wellness Support

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2022-11-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Disorder, Major Bipolar Disorder Schizo Affective Disorder Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel design

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Cognitive Adaptation Training (CAT)

A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.

Group Type ACTIVE_COMPARATOR

CAT

Intervention Type BEHAVIORAL

An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.

Remote Cognitive Adaptation Training (R-CAT)

A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.

Group Type ACTIVE_COMPARATOR

R-CAT

Intervention Type BEHAVIORAL

An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.

Interventions

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CAT

An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.

Intervention Type BEHAVIORAL

R-CAT

An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Adaptation Training Remote Cognitive Adaptation Training

Eligibility Criteria

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Inclusion Criteria

1. Able to give informed consent.
2. Between the ages of 18 and 65.
3. Clinical Diagnosis of Major Depressive Disorder, Bipolar disorder, Schizophrenia, or Schizoaffective Disorder
4. Receiving treatment with oral psychiatric medications.
5. Have had a hospitalization or emergency department visit in the past year
6. 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
7. Responsible for taking their own medications
8. 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
9. 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
10. Report on prescreen research call with research team that they have no plans to change their MCO in the next 12 months
11. Have a working smart phone
12. Able to understand and complete rating scales and assessments.
13. Agree to home visits for intervention and to count pills and conduct assessments

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No