Partnership in Implementation Science for Geriatric Mental Health (PRISM)

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.

Study Overview

• Status: Recruiting
• Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD)
• Intervention / Treatment: Behavioral: Physical Exercise Intervention

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 Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Komatra Chuengsatiansup, MD; Phone Number: +66814411401; Email: loxlix@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Ministry of Public Health
    • Contact: Komatra Chuengsatiansup, MD; Phone Number: +66 626016116; Email: loxlix@gmail.com
    • Contact: Siranee Sihapark, PhD; Phone Number: +66 810551215; Email: daosiam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 53 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEI-GTO-ThAI; Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model	Behavioral: Physical Exercise Intervention; The 12-week physical exercise intervention will be delivered by trained community health workers (CHW) who are supervised by nurses. The CHW will visit the patient's home-3 sessions per week for the first 2 weeks, followed by weekly visits for 6 weeks, and then weekly telephone support for 4 weeks-to instruct the family caregiver and the patient in the exercise routine. Each session includes physical activities designed to promote gentle stretching, strength, balance, flexibility, and endurance, with a progressive schedule (i.e., the total length of time increases from 10 minutes up to 30 minutes maximum) and its intensity adjusted based on the participant's level of fitness.
Active Comparator: PEI-Standard; Physical exercise intervention (PEI) supported by the standard governmental administrative procedures	Behavioral: Physical Exercise Intervention; The 12-week physical exercise intervention will be delivered by trained community health workers (CHW) who are supervised by nurses. The CHW will visit the patient's home-3 sessions per week for the first 2 weeks, followed by weekly visits for 6 weeks, and then weekly telephone support for 4 weeks-to instruct the family caregiver and the patient in the exercise routine. Each session includes physical activities designed to promote gentle stretching, strength, balance, flexibility, and endurance, with a progressive schedule (i.e., the total length of time increases from 10 minutes up to 30 minutes maximum) and its intensity adjusted based on the participant's level of fitness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation outcome score	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).	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral and psychological symptoms of dementia (BPSD)	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: University of California, Davis; University of South Carolina; Society and Health Institute (Thailand); Shanghai Mental Health Center (China)
• Investigators: Principal Investigator: Hongtu Chen, PhD, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 2017P000186/PHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We don't have a plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No