A Multidomain Intervention Program for Older People With Dementia

Study Overview
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Brief Summary
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This is a pilot study to assess the feasibility of a multidomain intervention for older people with dementia in nursing homes. Participants will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). The intervention will include physical, cognitive, and social interventions and management of metabolic and vascular risk factors. We hypothesize that the multidomain intervention will be feasible in Vietnam, and participants who receive the intervention will show improvement in cognitive function, quality of life, behaviors, functional ability, sleep, and in reduction of falls, use of healthcare services, and death rate compared to those in the control group during the 6 months intervention period and after the 6 months extended follow-up.

Detailed Description
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This is a two-armed, 12 month, multicenter, randomized controlled pilot study, based in 3 nursing homes in Hanoi, Vietnam. The study PI and/or researchers in the research team will contact adults aged 60 years and older in the nursing homes to introduce the study. If they are interested in participating, the study PI and/or researchers in the research team will screen them for their eligibility. If they meet the inclusion criteria and are interested in participating, written informed consent will be obtained. Participants who agreed to participate in the study will be randomized into two equal groups, to receive either an intensive multidomain intervention (intervention group) or regular health advice (control group). Participants in both the intervention and the control groups will be treated for dementia according to the recommendations of the Vietnam Alzheimer's Disease and Neurocognitive Disorders Association. All participants will meet the study physician to have an examination at baseline, 3 months, and 6 months. At each examination, participants will undergo a physical examination, anthropometry (weight, hip and waist circumference), blood pressure determination, pulse rate and rhythm, risks of cardiovascular and metabolic diseases (smoking, drinking, hypertension, coronary artery disease, dyslipidemia, atherosclerosis, diabetes) and assess blood test results (lipid profile, HbA1C, and fasting glucose if patients have diabetes). Results will be provided to participants and their doctors. In addition to what is given to both groups, participants in the intervention group will receive four intervention components: (1) physical activity intervention; (2) cognitive intervention; (3) social intervention; and (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions. All outcome measures will be administered at baseline, 6 months, and extended follow-up at 12 months.

Official Title
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A Multidomain Intervention Program for Older People With Dementia: A Pilot Study

Conditions
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Dementia, Alzheimer Disease, Dementia, Mixed

Intervention / Treatment
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* Behavioral: Physical activity intervention
* Behavioral: Cognitive stimulation intervention
* Behavioral: Social intervention
* Other: Management of metabolic and vascular risk factors


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance. Exclusion criteria are: Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke) Symptomatic cardiovascular disease, coronary revascularization within 1 year Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria) Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment) g. Participant or family unwilling to participate in the study

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Physical activity intervention: Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home. Cognitive stimulation intervention: The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. Social intervention: The social intervention will be combined with physical and cognitive interventions by doing in a group. Metabolic and vascular risk factors: Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists in the study. | Behavioral: Physical activity intervention<br>* Progressive resistance training (PRT) for the physical intervention will be provided at the nursing home for 45 minutes twice a week. The sessions will be organized in groups (10 patients/ group) and supervised by 2 physiotherapists. Within each small group (maximum 10), participants will follow the program tailored to their individual functioning level, with constant oversight by trainers. People with dementia and care staff will be instructed to follow the prescribed PRT exercises for the rest of the week. Subjects will be encouraged to exercise daily.<br>Behavioral: Cognitive stimulation intervention<br>* The study subjects will receive cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The intervention involves 14 sessions of themed activities, which typically run twice weekly. The sessions will be organized in groups (10 patients/ group). People with dementia and their care staff will be instructed on how to practice the various activities at their nursing home for the rest of the week.<br>Behavioral: Social intervention<br>* Social intervention will be combined with physical and cognitive interventions through doing these in a group, playing games during exercises (dancing, throwing ball to each other) or doing cognitive stimulation therapy in a group.<br>Other: Management of metabolic and vascular risk factors<br>* Study physicians will assess the risk of developing new chronic diseases, change in blood pressure, weight and BMI, and hip and waist circumference, blood test (glucose, lipid parameters, fasting glucose, and HbA1C if the person with dementia has diabetes) at 3 and 6 months. Participants in the intervention group will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologists and endocrinologists. The target for blood pressure is less than 120/90 mmHg and the target for HbA1c is less than 7.5 %.<br>|
| No Intervention: Control group<br>The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence (the day and time) | Attendance (the day and time) at each visit will be recorded for each component of the intervention. | 6 months | 
| Adherence (training diary) | Researchers also assess adherence by checking the participant's training diary. | 6 months | 
| Retention | The retention rate will be calculated as the percentage of participants in each group who did not discontinue the study. | 6 months | 
| Reasons for dropouts | Reasons for dropouts will be documented. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global cognition | Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) 13-item version; a higher score indicates poorer performance and greater impairment. | Baseline, 6 months, and 12 months | 
| Dementia severity via CDR | Dementia severity will be assessed by using Clinical Dementia Rating (CDR). The CDR score ranges from 0-3 (no dementia (CDR = 0), questionable dementia (CDR = 0.5), mild dementia (CDR = 1), moderate dementia (CDR = 2), and severe dementia (CDR = 3) | Baseline, 6 months, and 12 months | 
| Dementia severity via MMSE | Dementia severity will be assessed using Mini-Mental State Examination (MMSE), a low score being indicative of cognitive deterioration | Baseline, 6 months, and 12 months | 
| Executive function via Clock drawing test | Excutive function will be assessed using Clock drawing test. | Baseline, 6 months, and 12 months | 
| Executive function via Trails B test | Executive function will be assessed using Trails B test, higher scores reveal greater impairment | Baseline, 6 months, and 12 months | 
| Attention function via digit span forward | Attention function will be assessed using digit span forward. | Baseline, 6 months, and 12 months | 
| Attention function via Trials A | Attention function will be assessed using Trials A, higher scores reveal greater impairment | Baseline, 6 months, and 12 months | 
| Behavioral and psychological symptoms of dementia (BPSD) | Behavioral and psychological symptoms of dementia (BPSD) (e.g., agitation, aggression, depression) will be measured by interviewing staff using the Neuropsychiatric Inventory (NPI) questionnaire to assess the BPSD. The severity scale has scores ranging from 1 to 3 points (1=mild; 2=moderate; and 3=severe) and the scale for assessing caregiver distress has scores ranging from 0 to 5 points (0=no distress; 5=extreme distress). | Baseline, 6 months, and 12 months | 
| Functional ability via Barthel index | Functional ability will be assessed using Barthel index, lower scores indicating increased disability | Baseline, 6 months, and 12 months | 
| Functional ability via SPPB | Functional ability will be assessed using the Short Physical Performance Battery (SPPB), lower scores indicating increased disability | Baseline, 6 months, and 12 months | 
| Functional ability via the handgrip strength | Functional ability will be assessed via the handgrip strength. | Baseline, 6 months, and 12 months | 
| Functional ability via Timed Up & Go test | Fall risks will be assessed using Timed Up & Go test. | Baseline, 6 months, and 12 months | 
| Prevalence of falls | Falls will be assessed by asking the participants, caregivers, and care staff the number of falls in the 12 months prior baseline and in the 12 months during the study period. | Baseline, 6 months, and 12 months | 
| Quality of sleep | Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers | Baseline, 6 months, and 12 months | 
| Health-related quality of life | Health-related quality of life will be assessed with the Quality of Life in Alzheimer's Disease scale (QoL-AD), a higher score indicates better quality of life. | Baseline, 6 months, and 12 months | 
| Utilization of health services | Use of healthcare services will be assessed though number of admissions to hospital, visits to the emergency department. | Baseline, 6 months, and 12 months | 
| Death | Death will be assessed through reports from care staff, nursing home records. | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Multidomain intervention, Older people