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Partnership in Implementation Science for Geriatric Mental Health (PRISM)

NCT03264378 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2021-04-30

No results posted yet for this study

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.

Conditions

  • Behavioral and Psychological Symptoms of Dementia (BPSD)

Interventions

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.

Sponsors & Collaborators

  • Society and Health Institute (Thailand)

    collaborator UNKNOWN

  • Shanghai Mental Health Center (China)

    collaborator UNKNOWN

  • University of South Carolina

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Hongtu Chen, PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03264378 on ClinicalTrials.gov