Behavioral and Psychological Symptoms of Dementia (BPSD)NCT03264378
Partnership in Implementation Science for Geriatric Mental Health (PRISM)
A study testing Physical Exercise Intervention in people with Behavioral and Psychological Symptoms of Dementia (BPSD), run by Brigham and Women's Hospital at 1 site in Thailand.
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). Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral and Psychological Symptoms of Dementia (BPSD)
- What is being tested?
- Physical Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (a) caregivers who are cognitively not intact, and/or
- (b) not willing to participate in the intervention.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ministry of Public Health
Bangkok
Komatra Chuengsatiansup, MD, +66 626016116, loxlix@gmail.com
Siranee Sihapark, PhD, +66 810551215, daosiam@gmail.com
About this study
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.
Read the 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.
- Being tested
- Physical Exercise Intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| PEI-GTO-ThAI | Experimental | Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model Receives: Behavioral: Physical Exercise Intervention |
| PEI-Standard | Active comparator | Physical exercise intervention (PEI) supported by the standard governmental administrative procedures Receives: Behavioral: Physical Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Secondary outcomes (1)
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavioral and Psychological Symptoms of Dementia (BPSD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Society and Health Institute (Thailand), Shanghai Mental Health Center (China), University of South Carolina, University of California, Davis
- Responsible party
- Principal investigator, Hongtu Chen, Brigham and Women's Hospital
- Investigators
- Hongtu Chen, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264378
- Sponsor's protocol ID
- 2017P000186/PHS
- Status last verified
- Apr 2021
- First submitted
- 24 Aug 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have a plan to share individual participant data.
Publications
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.
PubMed 34126778
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership in Implementation Science for Geriatric Mental Health (PRISM)
- ClinicalTrials.gov ID
- NCT03264378
- Acronym / sponsor ID
- 2017P000186/PHS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Society and Health Institute (Thailand), Shanghai Mental Health Center (China), University of South Carolina, University of California, Davis
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEI-GTO-ThAI | Experimental | Behavioral: Physical Exercise InterventionPhysical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model |
| PEI-Standard | Active comparator | Behavioral: Physical Exercise InterventionPhysical exercise intervention (PEI) supported by the standard governmental administrative procedures |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (2 listed)
- (a) caregivers who are cognitively not intact, and/or
- (b) not willing to participate in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise InterventionThe 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. | Behavioural | PEI-GTO-ThAI, PEI-Standard |
Primary outcome
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).
1 secondary outcome
Behavioral and psychological symptoms of dementia (BPSD)
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 34126778Chen 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.
- Individual participant dataSharing planned: No. We don't have a plan to share individual participant data.
Related trials for Behavioral and Psychological Symptoms of Dementia (BPSD)
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Web-Based Psychoeducation for Dementia Caregivers
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Transcranial Random Noise (tRNS) for BPSD in Alzheimer's Disease: A Double-blind Randomized Controlled Trial
Transcranial Random Noise Stimulation (tRNS), Electroencephalography
Recruiting
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia
BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion
Recruiting
SUNAM Protocol for Managing BPSD
Dementia
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Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongtu Chen, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise Intervention in people with Behavioral and Psychological Symptoms of Dementia (BPSD), run by Brigham and Women's Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Komatra Chuengsatiansup, MD (+66814411401, loxlix@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation outcome score (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.