Alzheimer Disease, Dementia, Dementia, Mixed
Conditions
Keywords
Dementia, Multidomain intervention, Older people
Brief summary
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, and death rate compared to those in the control group during the 6 months intervention period
Detailed description
This is a two-armed, 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
Interventions
BEHAVIORALPhysical activity intervention
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 (6-10 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.
BEHAVIORALCognitive stimulation intervention
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 (6-10 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.
BEHAVIORALSocial intervention
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.
OTHERManagement of metabolic and vascular risk factors
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 8 %.
Sponsors
National Geriatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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: 1. Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke) 2. Symptomatic cardiovascular disease, coronary revascularization within 1 year 3. Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria) 4. Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 6 months | Percentageof sessions attended out of the total planned |
| Retention | 6 months | The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attention Function Via Digit Span Forward | Baseline, 6 months | Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention |
| Atttention Function Will be Assessed Using Digit Span Backward. | Baseline, 6 months | Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention |
| Behavioral and Psychological Symptoms of Dementia (BPSD) | Baseline, 6 months | Behavioral and psychological symptoms of dementia (BPSD) will be measured using the Neuropsychiatric Inventory (NPI) questionnaire. The total NPI score ranging from 0 to 144 points. Higher scores indicate greater severity of BPSD |
| Total Dependence of Participants Assessed Using the Barthel Index | Baseline, 6 months | Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence. |
| Functional Ability Via the Handgrip Strength | Baseline, 6 months | Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability |
| Functional Ability Via 30 Seconds Sit To Stand Test | Baseline, 6 months | Count the total number of complete stands executed in 30 seconds |
| Global Cognition | Baseline, 6 months | Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); score ranging from 0-70, a higher score indicates worse impairment. |
| Quality of Sleep | Baseline, 6 months | Quality of sleep will be assessed using Pittsburgh Sleep Quality Index. A global PSQI score greater than 5 distinguishing good and poor sleepers |
| Health-related Quality of Life | Baseline, 6 months | Health-related quality of life will be assessed using the Quality of Life in Alzheimer's Disease scale. The Quality of Life in Alzheimer's Disease scale measures the overall quality of life in individuals with Alzheimer's disease. It consists of 13 items, each rated on a 4-point Likert scale. The total score is obtained by summing the scores of all 13 items, resulting in a possible range from 13 to 52 points. Higher scores indicate a better quality of life. |
| Death | 6 months | Death will be assessed through reports from care staff, nursing home records. |
| Functional Ability Via the Instrumental Activities of Daily Living Scale | Baseline, 6 months | Functional ability will be assessed using the Instrumental Activities of Daily Living Scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men. |
| Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale | Baseline, 6 months | Dependence will be assessed using the Instrumental Activities of Daily Living scale, which evaluates the ability to perform eight daily tasks, including using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and financial management. The total score ranges from 0 to 8, with 8 indicating full independence and scores below 8 suggesting dependence in functional activities. |
| Fall | Baseline, 6 months | Falls will be assessed by the fall incident report at baseline and during the study period |
| Executive Function Via Clock Drawing Test | Baseline, 6 months | Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions | 30 |
| Control Group 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Return home | 1 | 3 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 28 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Continuous Number | 78 years STANDARD_DEVIATION 7.4 | 78 years STANDARD_DEVIATION 8.8 | 78 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment Vietnam | 30 participants | 30 participants | 60 participants |
| Severity of dementia Mild | 11 Participants | 11 Participants | 22 Participants |
| Severity of dementia Moderate | 19 Participants | 19 Participants | 38 Participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Adherence
Percentageof sessions attended out of the total planned
Time frame: 6 months
Population: Adherence was only assessed for the intervention group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Adherence | 85.4 percentage of Adherence |
Primary
Retention
The retention rate was calculated as the number (percentage) of participants in each group who did not discontinue the study.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Retention | 1 Participants |
| Control Group | Retention | 3 Participants |
Secondary
Attention Function Via Digit Span Forward
Attention function will be assessed using digit span forward. Scores range from 0-12. Higher scores indicated better attention
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Attention Function Via Digit Span Forward | Baseline | 8.9 score on a scale | Standard Deviation 2.5 |
| Intervention Group | Attention Function Via Digit Span Forward | After intervention | 9 score on a scale | Standard Deviation 2.2 |
| Control Group | Attention Function Via Digit Span Forward | Baseline | 9.5 score on a scale | Standard Deviation 2.2 |
| Control Group | Attention Function Via Digit Span Forward | After intervention | 9.1 score on a scale | Standard Deviation 2.8 |
Secondary
Atttention Function Will be Assessed Using Digit Span Backward.
Higher scores indicated better attention. Scores range from 0-12. Higher scores indicated better attention
Time frame: Baseline, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Atttention Function Will be Assessed Using Digit Span Backward. | Baseline | 2.5 score on a scale | Standard Deviation 1.5 |
| Intervention Group | Atttention Function Will be Assessed Using Digit Span Backward. | After intervention | 2.7 score on a scale | Standard Deviation 1.5 |
| Control Group | Atttention Function Will be Assessed Using Digit Span Backward. | Baseline | 2.6 score on a scale | Standard Deviation 1.3 |
| Control Group | Atttention Function Will be Assessed Using Digit Span Backward. | After intervention | 3 score on a scale | Standard Deviation 1.3 |
Secondary
Behavioral and Psychological Symptoms of Dementia (BPSD)
Behavioral and psychological symptoms of dementia (BPSD) will be measured using the Neuropsychiatric Inventory (NPI) questionnaire. The total NPI score ranging from 0 to 144 points. Higher scores indicate greater severity of BPSD
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Behavioral and Psychological Symptoms of Dementia (BPSD) | Baseline | 1 score on a scale | Standard Deviation 1.7 |
| Intervention Group | Behavioral and Psychological Symptoms of Dementia (BPSD) | After intervention | 0.8 score on a scale | Standard Deviation 1.7 |
| Control Group | Behavioral and Psychological Symptoms of Dementia (BPSD) | Baseline | 1 score on a scale | Standard Deviation 1.9 |
| Control Group | Behavioral and Psychological Symptoms of Dementia (BPSD) | After intervention | 0.9 score on a scale | Standard Deviation 1.7 |
Secondary
Death
Death will be assessed through reports from care staff, nursing home records.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Death | 0 participants |
| Control Group | Death | 0 participants |
Secondary
Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale
Dependence will be assessed using the Instrumental Activities of Daily Living scale, which evaluates the ability to perform eight daily tasks, including using the telephone, shopping, meal preparation, housekeeping, laundry, transportation, medication management, and financial management. The total score ranges from 0 to 8, with 8 indicating full independence and scores below 8 suggesting dependence in functional activities.
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale | Dependent (baseline) | 26 participants |
| Intervention Group | Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale | Dependent (After intervention) | 23 participants |
| Control Group | Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale | Dependent (baseline) | 29 participants |
| Control Group | Dependence of Participants Assessed Using the Instrumental Activities of Daily Living Scale | Dependent (After intervention) | 27 participants |
Secondary
Executive Function Via Clock Drawing Test
Excutive function will be assessed using Clock drawing test. Scores range from 0-10, with lower scores indicating greater cognitive impairment
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Executive Function Via Clock Drawing Test | Baseline | 0.5 score on a scale | Standard Deviation 1.6 |
| Intervention Group | Executive Function Via Clock Drawing Test | After intervention | 2.3 score on a scale | Standard Deviation 3.4 |
| Control Group | Executive Function Via Clock Drawing Test | After intervention | 2.7 score on a scale | Standard Deviation 3.8 |
| Control Group | Executive Function Via Clock Drawing Test | Baseline | 2.3 score on a scale | Standard Deviation 3 |
Secondary
Fall
Falls will be assessed by the fall incident report at baseline and during the study period
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Fall | Baseline | 11 Participants |
| Intervention Group | Fall | After intervention | 6 Participants |
| Control Group | Fall | Baseline | 8 Participants |
| Control Group | Fall | After intervention | 7 Participants |
Secondary
Functional Ability Via 30 Seconds Sit To Stand Test
Count the total number of complete stands executed in 30 seconds
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Functional Ability Via 30 Seconds Sit To Stand Test | Baseline | 4.5 events | Standard Deviation 4.2 |
| Intervention Group | Functional Ability Via 30 Seconds Sit To Stand Test | After intervention | 5.4 events | Standard Deviation 3.9 |
| Control Group | Functional Ability Via 30 Seconds Sit To Stand Test | Baseline | 3.4 events | Standard Deviation 4.6 |
| Control Group | Functional Ability Via 30 Seconds Sit To Stand Test | After intervention | 1.9 events | Standard Deviation 4 |
Secondary
Functional Ability Via the Handgrip Strength
Functional ability will be assessed via the handgrip strength. Higher scores indicated better functional ability
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Functional Ability Via the Handgrip Strength | Baseline | 8 kilograms | Standard Deviation 7.5 |
| Intervention Group | Functional Ability Via the Handgrip Strength | After intervention | 12.8 kilograms | Standard Deviation 6.4 |
| Control Group | Functional Ability Via the Handgrip Strength | Baseline | 12.4 kilograms | Standard Deviation 14.7 |
| Control Group | Functional Ability Via the Handgrip Strength | After intervention | 11.1 kilograms | Standard Deviation 6.1 |
Secondary
Functional Ability Via the Instrumental Activities of Daily Living Scale
Functional ability will be assessed using the Instrumental Activities of Daily Living Scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Functional Ability Via the Instrumental Activities of Daily Living Scale | Dependent (baseline) | 26 participants |
| Intervention Group | Functional Ability Via the Instrumental Activities of Daily Living Scale | Dependent (After intervention) | 23 participants |
| Control Group | Functional Ability Via the Instrumental Activities of Daily Living Scale | Dependent (baseline) | 29 participants |
| Control Group | Functional Ability Via the Instrumental Activities of Daily Living Scale | Dependent (After intervention) | 27 participants |
Secondary
Global Cognition
Global cognition will be measured by Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog); score ranging from 0-70, a higher score indicates worse impairment.
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Global Cognition | Baseline | 28 score on a scale | Standard Deviation 8.8 |
| Intervention Group | Global Cognition | After intervention (6 months) | 27.3 score on a scale | Standard Deviation 9.5 |
| Control Group | Global Cognition | Baseline | 24.5 score on a scale | Standard Deviation 8.5 |
| Control Group | Global Cognition | After intervention (6 months) | 29.1 score on a scale | Standard Deviation 9.9 |
Secondary
Health-related Quality of Life
Health-related quality of life will be assessed using the Quality of Life in Alzheimer's Disease scale. The Quality of Life in Alzheimer's Disease scale measures the overall quality of life in individuals with Alzheimer's disease. It consists of 13 items, each rated on a 4-point Likert scale. The total score is obtained by summing the scores of all 13 items, resulting in a possible range from 13 to 52 points. Higher scores indicate a better quality of life.
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Health-related Quality of Life | After intervention | 28.9 score on a scale | Standard Deviation 4.3 |
| Intervention Group | Health-related Quality of Life | Baseline | 27.3 score on a scale | Standard Deviation 4.4 |
| Control Group | Health-related Quality of Life | Baseline | 33.6 score on a scale | Standard Deviation 4.6 |
| Control Group | Health-related Quality of Life | After intervention | 34.4 score on a scale | Standard Deviation 4.1 |
Secondary
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
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Quality of Sleep | Poor sleep (baseline) | 26 participants |
| Intervention Group | Quality of Sleep | Poor sleep (after intervention) | 19 participants |
| Control Group | Quality of Sleep | Poor sleep (baseline) | 17 participants |
| Control Group | Quality of Sleep | Poor sleep (after intervention) | 17 participants |
Secondary
Total Dependence of Participants Assessed Using the Barthel Index
Total dependence will be assessed using the Barthel Index, with a total score of 100, where scores between 0 and 20 indicate total dependence.
Time frame: Baseline, 6 months
Population: Data were analyzed on an intention-to-treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Total Dependence of Participants Assessed Using the Barthel Index | Total dependent (baseline) | 4 participants |
| Intervention Group | Total Dependence of Participants Assessed Using the Barthel Index | Total dependent (After intervention) | 4 participants |
| Control Group | Total Dependence of Participants Assessed Using the Barthel Index | Total dependent (baseline) | 2 participants |
| Control Group | Total Dependence of Participants Assessed Using the Barthel Index | Total dependent (After intervention) | 7 participants |