Partnership in Implementation Science for Geriatric Mental Health (PRISM)

• ClinicalTrials.gov Identifier: NCT03264378
• Recruitment Status: Not yet recruiting
• First Posted: August 29, 2017
• Last Update Posted: August 30, 2017
• 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
• Information provided by (Responsible Party): Hongtu Chen, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: August 24, 2017
• First Posted Date: August 29, 2017
• Last Update Posted Date: August 30, 2017
• Estimated Study Start Date: February 1, 2019
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2017)

Implementation outcome score [ Time Frame: 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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 25, 2017)

Behavioral and psychological symptoms of dementia (BPSD) [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Partnership in Implementation Science for Geriatric Mental Health (PRISM)
• Official Title: Partnership in Implementation Science for Geriatric Mental Health (PRISM)
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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.

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

• Condition: Behavioral and Psychological Symptoms of Dementia (BPSD)

Intervention

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.

Study Arms

• Experimental: PEI-GTO-ThAI
  Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model
  Intervention: Behavioral: Physical Exercise Intervention
• Active Comparator: PEI-Standard
  Physical exercise intervention (PEI) supported by the standard governmental administrative procedures
  Intervention: Behavioral: Physical Exercise Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 25, 2017): 350
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2022
• Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Komatra Chuengsatiansup, MD; +66814411401; loxlix@gmail.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03264378
• Other Study ID Numbers: 2017P000186/PHS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: We don't have a plan to share individual participant data.

• Responsible Party: Hongtu Chen, Brigham and Women's Hospital
• Study 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

Investigators

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

• PRS Account: Brigham and Women's Hospital
• Verification Date: August 2017