Clinical trial NCT03264378: Partnership in Implementation Science for Geriatric Mental Health (PRISM)
Official title: Partnership in Implementation Science for Geriatric Mental Health (PRISM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Society and Health Institute (Thailand)
name: Shanghai Mental Health Center (China)
name: University of South Carolina
name: University of California, Davis
First posted: 2017-08-29
Enrollment: 350
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will receive physical exercise intervention (PEI) that is supported by standardized administrative procedures plus the GTO-ThAI implementation support system designed to improve the quality of implementation of the PEI program. The active comparator group will receive PEI that is supported only by standardized administrative procedures that the Thai government typically uses to promote policy-driven initiatives.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Partnership in Implementation Science for Geriatric Mental Health (PRISM) project proposes an evidence-based physical exercise intervention for older adults who exhibit behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation support, with a control arm, which receives usual top-down administrative instruction for implementing a policy initiative.

Detailed description: The overall goal of this project is to establish a hub to integrate implementation research for scaling up sustainable, evidence-based mental health interventions with research capacity-building activities for East Asia. Specific scale-up study aims include: Aim 1: Assessing readiness for implementing the evidence-based physical exercise intervention for improving mental health of older adults in participating provinces of Thailand; Aim 2: Developing the GTO-ThAI implementation support model through a pre-implementation case study and formative evaluation; and Aim 3: Evaluation of implementation strategies and clinical outcomes through a hybrid Type 3 randomized trial to test an evidence-based implementation support strategy (i.e., the GTO-ThAI model) that emphasizes a systematic process to address implementation barriers to the delivery of the evidence-based physical exercise intervention (PEI), compared with the existing standard administrative procedures for delivering the same PEI.

Eligibility criteria: Inclusion Criteria:

* (a) adults who are aged 55 and older,
* (b) screen positive for dementia,
* (c) screen positive for BPSD, and
* (d) having a caregiver who is willing to participate in the study.

Exclusion Criteria:

* (a) caregivers who are cognitively not intact, and/or
* (b) not willing to participate in the intervention.

Primary outcomes:
measure: Implementation outcome score
timeFrame: Up to 12 months
Secondary outcomes:
measure: Behavioral and psychological symptoms of dementia (BPSD)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ministry of Public Health
Study officials:
affiliation: Brigham and Women's Hospital
name: Hongtu Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen H, Levkoff S, Chuengsatiansup K, Sihapark S, Hinton L, Gallagher-Thompson D, Tongsiri S, Wisetpholchai B, Fritz S, Lamont A, Domlyn A, Wandersman A, Marques AH. Implementation Science in Thailand: Design and Methods of a Geriatric Mental Health Cluster-Randomized Trial. Psychiatr Serv. 2022 Jan 1;73(1):83-91. doi: 10.1176/appi.ps.202000028. Epub 2021 Jun 15.