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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

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 Not Applicable

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  (Clinical Trial)
Estimated 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.
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)
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264378


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

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

Responsible Party: Hongtu Chen, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03264378     History of Changes
Other Study ID Numbers: 2017P000186/PHS
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We don't have a plan to share individual participant data.

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

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders