Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Mass General Brigham

Status: Unknown

Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD)

Treatments: Behavioral: Physical Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03264378

2017P000186/PHS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 2 patient groups

PEI-GTO-ThAI

Experimental group

Description:

Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model

Treatment:

Behavioral: Physical Exercise Intervention

PEI-Standard

Active Comparator group

Description:

Physical exercise intervention (PEI) supported by the standard governmental administrative procedures

Treatment:

Behavioral: Physical Exercise Intervention