Partnership in Implementation Science for Geriatric Mental Health (PRISM)

NCT03264378 | Unknown

• 1 other identifier: 2017P000186/PHS
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavioral and Psychological Symptoms of Dementia (BPSD)

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 months

Secondary Outcomes (1)

• Behavioral and psychological symptoms of dementia (BPSD)

  Up to 12 months

Study Arms (2)

PEI-GTO-ThAI

EXPERIMENTAL

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

Behavioral: Physical Exercise Intervention

PEI-Standard

ACTIVE COMPARATOR

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

Behavioral: Physical Exercise Intervention

Interventions

Physical Exercise Intervention BEHAVIORAL

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.

PEI-GTO-ThAI; PEI-Standard

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (a) caregivers who are cognitively not intact, and/or
• (b) not willing to participate in the intervention.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Society and Health Institute (Thailand): collaborator
• Shanghai Mental Health Center (China): collaborator
• University of South Carolina: collaborator
• University of California, Davis: collaborator

Study Sites (1)

Ministry of Public Health

Bangkok, Thailand

RECRUITING

Related Publications (1)

• 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.

  PMID: 34126778 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Hongtu Chen, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Komatra Chuengsatiansup, MD

CONTACT

+66814411401; loxlix@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: None of participants, care providers, or outcome assessor knows whether which participants have been assigned to intervention or control condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 29, 2017
• Study Start: June 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)