Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Behavioral and Psychological Symptoms of Dementia (BPSD) Clinical Trial

Official title:

Partnership in Implementation Science for Geriatric Mental Health (PRISM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264378
• Other study ID #: 2017P000186/PHS
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Brigham and Women's Hospital
• Contact: Komatra Chuengsatiansup, MD
• Phone: +66814411401
• Email: loxlix[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Thailand	Ministry of Public Health	Bangkok

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Shanghai Mental Health Center (China), Society and Health Institute (Thailand), University of California, Davis, University of South Carolina

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Behavioral and psychological symptoms of dementia (BPSD)	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.	Up to 12 months