Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Not Applicable

• Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD)
• Interventions: Behavioral: Physical Exercise Intervention

• Registration Number: NCT03264378
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Study Start: 2020-06-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEI-GTO-ThAI	Physical Exercise Intervention	Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model
PEI-Standard	Physical Exercise Intervention	Physical exercise intervention (PEI) supported by the standard governmental administrative procedures

Primary Outcome Measures

Name	Time	Method
Implementation outcome score	Up to 12 months	Adapted from the Quality Implementation Tool (Meyer et al., 2012), using a total score based on average of ratings, by site implementation team leaders, on a 7-point Likert scale over 48 items across eight dimensions of implementation (e.g. adoption, fidelity, dosage, program reach, differentiation, quality of implementation, implementation cost, sustainability).

Secondary Outcome Measures

Name	Time	Method
Behavioral and psychological symptoms of dementia (BPSD)	Up to 12 months	BPSD will be assessed by the Neuropsychiatric Inventory (NPI), using the total score obtained by summing all the individual domain total scores; each domain score is the product of the frequency score multiplied by the severity score for that behavioral domain.

Trial Locations

Locations (1)

Ministry of Public Health; 🇹🇭 Bangkok, Thailand