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Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Primary Purpose

Behavioral and Psychological Symptoms of Dementia (BPSD)

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Physical Exercise Intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Behavioral and Psychological Symptoms of Dementia (BPSD)

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Ministry of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEI-GTO-ThAI

PEI-Standard

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
August 24, 2017
Last Updated
April 29, 2021
Sponsor
Brigham and Women's Hospital
Collaborators
Society and Health Institute (Thailand), Shanghai Mental Health Center (China), University of South Carolina, University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03264378
Brief Title
Partnership in Implementation Science for Geriatric Mental Health (PRISM)
Official Title
Partnership in Implementation Science for Geriatric Mental Health (PRISM)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Society and Health Institute (Thailand), Shanghai Mental Health Center (China), University of South Carolina, University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral and Psychological Symptoms of Dementia (BPSD)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
None of participants, care providers, or outcome assessor knows whether which participants have been assigned to intervention or control condition.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEI-GTO-ThAI
Arm Type
Experimental
Arm Description
Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model
Arm Title
PEI-Standard
Arm Type
Active Comparator
Arm Description
Physical exercise intervention (PEI) supported by the standard governmental administrative procedures
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implementation outcome score
Description
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).
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Behavioral and psychological symptoms of dementia (BPSD)
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Komatra Chuengsatiansup, MD
Phone
+66814411401
Email
loxlix@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongtu Chen, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Public Health
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Komatra Chuengsatiansup, MD
Phone
+66 626016116
Email
loxlix@gmail.com
First Name & Middle Initial & Last Name & Degree
Siranee Sihapark, PhD
Phone
+66 810551215
Email
daosiam@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We don't have a plan to share individual participant data.
Citations:
PubMed Identifier
34126778
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.
Results Reference
derived

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Partnership in Implementation Science for Geriatric Mental Health (PRISM)

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