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Partnership in Implementation Science for Geriatric Mental Health (PRISM)

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ClinicalTrials.gov Identifier: NCT03264378
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
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  ICMJE August 24, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 30, 2017
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Partnership in Implementation Science for Geriatric Mental Health (PRISM)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Behavioral and Psychological Symptoms of Dementia (BPSD)
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Komatra Chuengsatiansup, MD +66814411401 loxlix@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03264378
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • Society and Health Institute (Thailand)
  • Shanghai Mental Health Center (China)
  • University of South Carolina
  • University of California, Davis
Investigators  ICMJE
Principal Investigator: Hongtu Chen, PhD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP