Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03264378

Collaborator

Society and Health Institute (Thailand) (Other), Shanghai Mental Health Center (China) (Other), University of South Carolina (Other), University of California, Davis (Other)

350

Enrollment

Location

Arms

Anticipated Duration (Months)

21.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Behavioral and Psychological Symptoms of Dementia (BPSD)	Behavioral: Physical Exercise Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

None of participants, care providers, or outcome assessor knows whether which participants have been assigned to intervention or control condition.

Primary Purpose:

Health Services Research

Official Title:

Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ministry of Public Health	Bangkok		Thailand

Sponsors and Collaborators

Brigham and Women's Hospital
Society and Health Institute (Thailand)
Shanghai Mental Health Center (China)
University of South Carolina
University of California, Davis

Investigators

Principal Investigator: Hongtu Chen, PhD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongtu Chen, Assistant Professor, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT03264378

Other Study ID Numbers:

2017P000186/PHS

First Posted:

Aug 29, 2017

Last Update Posted:

Apr 30, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Apr 30, 2021