Depressive Disorder, NOS, Dysthymic Disorder, Major Depressive Disorder
Conditions
Brief summary
The goal of this open-administration treatment study of citalopram (or duloxetine) is to evaluate the effect of antidepressant medication on treating the syndrome of frailty in older adults with depressive symptoms. Patients with significant depressive symptoms (defined as CES-D (Center for Epidemiological Studies - Depression scale) \> 10) and 1 or more symptoms of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8 weeks to test whether antidepressant medication improves both the syndrome of frailty and depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and eligible to participate in the study will be treated with an antidepressant medication and assessed on the primary outcome variables (characteristics of frailty, depressive symptoms) as well as on secondary variables which include cognition (global cognition, episodic memory, executive function), and function (physical mobility, instrumental activities of daily living, and social functioning) prior to treatment initiation and following 8-weeks of treatment. The hypotheses for this protocol predict that we will discover a significant improvement on both frailty characteristics and depressive symptoms in this clinical population when treated with antidepressant medication (citalopram or duloxetine).
Detailed description
Frailty, a syndrome of decreased resiliency and reserves, is defined by five characteristics: 1)shrinking (definition: unintentional weight loss of \> 10 lbs in prior year, or \> 5% loss of body weight in prior year at follow-up), 2) weakness (definition: grip strength in lowest 20% at baseline, adjusted for gender and BMI), 3) poor endurance/energy (definition: self-report of exhaustion on 2 items on the CES-D), 4) slowness (definition: slowest 20% on timed 4 meter or 15 foot walk, adjusted for gender and standing height), and 5) low physical activity (definition: weighted score of kilocalories expended per week as calculated from the Minnesota Leisure Time Activity questionnaire). Frailty is associated with poor prognosis including hospitalization, falls, worsening disability and mobility, and death. Data from the Cardiovascular Health Study document the rate of comorbid depressive symptoms in frail older adults (16.2% of older adults with at least 1 frailty characteristic had a CES-D \> 10, including 31% of older adults with 3 or more frailty characteristics, compared to 2.6% of nonfrail older adults) despite study exclusion of individuals who were taking an antidepressant (this is in part why we chose to include patients with a CES-D of \> 10, rather than requiring a diagnosis of a depressive disorder such as major depression or dysthymia for this study). The relationship between frailty and depression however goes beyond this association; the five defining characteristics of frailty (exhaustion, decreased energy, weight loss, decreased grip strength, and slow/unsteady gait) overlap significantly with symptoms of geriatric depression (decreased energy and motivation, psychomotor slowing, weight loss, decreased participation in leisure activities). The proposed study is innovative in that it is focuses on a group of older adults who have been unrepresented (via exclusion criteria) in previous clinical studies (frail older adults with comorbid depressive symptoms), and it treats the comorbid depressive symptoms and targets characteristics of the frailty syndrome in the hopes of altering the prognostic trajectory of this clinical sample. This protocol serves two purposes: 1. It tests the feasibility of recruiting and retaining frail older adults with depressive symptoms in a treatment trial, and 2. It provides pilot data for the effectiveness of an antidepressant medication on treating the characteristics of frailty and the comorbid depressive symptoms.
Interventions
If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Anyone with 1 or more characteristics of frailty * HRSD\>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia) * Capable of providing informed consent * Currently followed by a PCP (had an eval in last 6-months)
Exclusion criteria
* Acute cancer treatment * Acute, severe or unstable medical illness * End stage medical illness (e.g. liver, kidney, pulmonary) * Mini Mental Exam \< 24 or a diagnosis of dementia * Individuals who do not have capacity to consent * Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine dependence * History of psychosis or psychotic disorder or bipolar disorder * Patient is considered a significant risk of suicide * Subject is considered based on history to be unlikely to respond to the single agent antidepressant (i.e., subjects with treatment resistant depression, including subjects with previous treatment with ECT) * History of allergic or adverse reaction to escitalopram or duloxetine, or non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine (at least 4 weeks at dose of 90mg).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression (HRSD) | Week 8 | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. |
| Hamilton Depression Rating Scale (HRSD) | 12 Months | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. |
| Hamilton Depression Rating Scale: Stratified by Baseline Frailty | Baseline (Week 0) | Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| World Health Organization Disability Assessment 2.0 (36-item) | Baseline (Week 0) | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). |
| World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | Baseline (Week 0) | Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medication Treatment Participants are treated with a flexible-dose antidepressant medication for a period of 8 weeks.
Antidepressant Medication: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Medication Treatment |
|---|---|
| Age, Continuous | 70.56 years STANDARD_DEVIATION 7.59 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Hamilton Rating Scale for Depression (HRSD) | 20.32 Score on a scale STANDARD_DEVIATION 5.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Region of Enrollment United States | 100 Participants |
| Sex: Female, Male Female | 66 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 2 / 100 |
Outcome results
Primary
Hamilton Depression Rating Scale (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: 12 Months
Population: Of the 71 who continued with treatment past 8-weeks, 11 dropped out between the 6- and 12-month assessment points. As such, 60 patients underwent 12-month assessments and were analyzable at 12-months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Depression Rating Scale (HRSD) | 13.6 score on a scale | Standard Deviation 7.48 |
Primary
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: Month 6
Population: Of the initial 100 patients assessed at baseline, 29 participants chose to not continue treatment past 8-weeks. As such, only 71 continued into the 10-month continuation phase of the project. Although these 29 were slightly older than the 71 who continued, they did not differ from those who continued in any other way including depression severity at baseline or 8-week treatment response. Because these 29 opted out of treatment after 8-weeks, only 71 were able to be analyzed at 6-months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 14.8 score on a scale | Standard Deviation 8.65 |
| Not/Intermediate Frail | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 10.8 score on a scale | Standard Deviation 5.85 |
Primary
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: Baseline (Week 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 21 score on a scale | Standard Deviation 6.61 |
| Not/Intermediate Frail | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 19.7 score on a scale | Standard Deviation 5.73 |
Primary
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: Week 8
Population: Although 100 patients were assessed at baseline, 4 dropped out during the course of the 8-week trial. This leaves an analyzable sample of 96.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 15.1 score on a scale | Standard Deviation 8.23 |
| Not/Intermediate Frail | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 11.6 score on a scale | Standard Deviation 7.21 |
Primary
Hamilton Depression Rating Scale: Stratified by Baseline Frailty
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: Month 12
Population: Of the 71 who continued with treatment past 8-weeks, 11 dropped out between the 6- and 12-month assessment points. As such, 60 patients underwent 12-month assessments and were analyzable at 12-months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 14.3 score on a scale | Standard Deviation 8.21 |
| Not/Intermediate Frail | Hamilton Depression Rating Scale: Stratified by Baseline Frailty | 13.0 score on a scale | Standard Deviation 6.91 |
Primary
Hamilton Rating Scale for Depression (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: 6 Months
Population: Of the initial 100 patients assessed at baseline, 29 participants chose to not continue treatment past 8-weeks. As such, only 71 continued into the 10-month continuation phase of the project. Although these 29 were slightly older than the 71 who continued, they did not differ from those who continued in any other way including depression severity at baseline or 8-week treatment response. Because these 29 opted out of treatment after 8-weeks, only 71 were able to be analyzed at 6-months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Rating Scale for Depression (HRSD) | 12.5 score on a scale | Standard Deviation 7.44 |
Primary
Hamilton Rating Scale for Depression (HRSD)
Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.
Time frame: Week 8
Population: Although 100 patients were assessed at baseline, 4 dropped out during the course of the 8-week trial. This leaves an analyzable sample of 96.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | Hamilton Rating Scale for Depression (HRSD) | 13.3 score on a scale | Standard Deviation 7.9 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Baseline (Week 0)
Population: Although 100 subjects enrolled in the study, only 12 subjects completed the baseline WHODAS assessment, so only 12 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item) | 71.7 score on a scale | Standard Deviation 24.8 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. Simple: the scores assigned to each of the items - none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. This approach is practical to use as a hand-scoring approach and may be the method of choice in busy clinical settings or in paper-pencil interview situations. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Week 8
Population: Although 100 subjects enrolled in the study, only 84 subjects completed the Week 8 WHODAS assessment, so only 84 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item) | 68.7 score on a scale | Standard Deviation 21.6 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: 6 Months
Population: Although 100 subjects enrolled in the study, only 64 subjects completed the Month 6 WHODAS assessment, so only 64 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item) | 66.7 score on a scale | Standard Deviation 20.9 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: 12 Months
Population: Although 100 subjects enrolled in the study, only 59 subjects completed the Month 12 WHODAS assessment, so only 59 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item) | 67.8 score on a scale | Standard Deviation 20.7 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Baseline (Week 0)
Population: Although 100 subjects enrolled in the study, only 12 subjects completed the baseline WHODAS assessment, so only 12 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 82.3 score on a scale | Standard Deviation 24.1 |
| Not/Intermediate Frail | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 56.8 score on a scale | Standard Deviation 18.8 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Week 8
Population: Although 100 subjects enrolled in the study, only 84 subjects completed the Week 8 WHODAS assessment, so only 84 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 77.9 score on a scale | Standard Deviation 22.8 |
| Not/Intermediate Frail | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 59.4 score on a scale | Standard Deviation 15.8 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Month 6
Population: Although 100 subjects enrolled in the study, only 64 subjects completed the Month 6 WHODAS assessment, so only 64 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 77.2 score on a scale | Standard Deviation 19.9 |
| Not/Intermediate Frail | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 58.0 score on a scale | Standard Deviation 17.5 |
Secondary
World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Time frame: Month 12
Population: Although 100 subjects enrolled in the study, only 59 subjects completed the Month 12 WHODAS assessment, so only 59 subjects' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication Treatment | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 80.9 score on a scale | Standard Deviation 18.1 |
| Not/Intermediate Frail | World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty | 56.7 score on a scale | Standard Deviation 15.8 |