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| ID | Type | Description | Link |
|---|---|---|---|
| A195000 | Other Identifier | UW Madison | |
| Protocol Version 10/20/2021 | Other Identifier | UW Madison | |
| ENGR/INDUSTRIAL ENGR | Other Identifier | UW Madison | |
| 1R18HS026853-01A1 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills.
The primary purpose of this study is to investigate whether voice-activated "smart" technology increases adoption and sustains use of an evidence-based electronic health intervention (Elder Tree, or ET) for older adults with multiple chronic conditions, and thereby improves its potential to widely enhance quality of life and health outcomes. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.
An Agency for Health Care Research and Quality (AHRQ)-funded randomized controlled trial (RCT) found that ET improved quality of life and other factors among high users of primary care with multiple chronic conditions such as diabetes and hypertension. However, many people did not use it extensively, which is a common problem with all web apps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants will receive treatment as usual (TAU). |
|
| ElderTree on laptop (ET- LT) | Experimental | Participants will receive ElderTree on a laptop. |
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| ElderTree on smart system (ET- SS) | Experimental | Participants will receive ElderTree on a smart system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ElderTree on laptop (ET- LT) | Behavioral | ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score | Pain interference was measured using the 4-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more pain interference. The possible range is 41.1 to 76.3 (PROMIS scores reported here have weighted ranges). | Baseline, 4 months, 8 months |
| Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score | Psychosocial quality of life was measured using the 12-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating better quality of life. The possible range is 21.2 to 67.6. | Baseline, 4 months, 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| ElderTree Days of Use | Days of ElderTree use within a 4 month period before their survey date. The possible range for days of ElderTree use is 0 to 120. | baseline to 4 months, and 4 months to 8 months |
| Physical Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
Require an interpreter
Have a medical diagnosis of any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Gustafson, PhD | UW-Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40961249 | Derived | Landucci G, Gustafson DH Sr, Mares ML, Pe-Romashko K, Curtin JJ, Hu Y, Maus A, Thompson K, Saunders S, Brown K, Woodburn J, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Randomized Controlled Trial. JMIR Aging. 2025 Nov 18;8:e75991. doi: 10.2196/75991. | |
| 35511229 | Derived | Gustafson DH Sr, Mares ML, Johnston DC, Landucci G, Pe-Romashko K, Vjorn OJ, Hu Y, Gustafson DH Jr, Maus A, Mahoney JE, Mutlu B. Using Smart Displays to Implement an eHealth System for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 May 5;11(5):e37522. doi: 10.2196/37522. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants will receive treatment as usual (TAU). |
| FG001 | ElderTree on Laptop (ET- LT) | Participants will receive ElderTree on a laptop. ElderTree on laptop (ET- LT): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT) |
| FG002 | ElderTree on Smart System (ET- SS) | Participants will receive ElderTree on a smart system. ElderTree on smart system (ET- SS): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants will receive treatment as usual (TAU). |
| BG001 | ElderTree on Laptop (ET- LT) | Participants will receive ElderTree on a laptop. ElderTree on laptop (ET- LT): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.1 - Pain Interference Score | Pain interference was measured using the 4-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more pain interference. The possible range is 41.1 to 76.3 (PROMIS scores reported here have weighted ranges). | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
8 months
Adverse events in Redcap
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants will receive treatment as usual (TAU). Treatment as usual (TAU): Treatment as usual (TAU) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Landucci | UW-Madison | (608) 890-1440 | gina.landucci@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 | Jul 22, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 20, 2022 | Jul 22, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| ElderTree on smart system (ET- SS) | Behavioral | ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. |
|
| Treatment as usual (TAU) | Behavioral | Treatment as usual (TAU) |
|
Physical quality of life was measured using the 12-item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more physical quality of life. The possible range is 16.2-67.7.
| Baseline, 4 months, 8 months |
| Pain Intensity | Pain intensity was measured using a single item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The item asked participants to answer regarding the past 7 days. The raw score of the item was used (range: 0-10); with higher values indicating more pain intensity. | Baseline, 4 months, 8 months |
| Number of Participants Readmitted Within 30-days | 30-day readmissions were measured using a single item asking participants to answer regarding the past 4 months. The raw score, answering yes/no to having a 30-day readmission, was used. Those participants answering 'yes' to being readmitted in the last 30 days are reported for each time point. | Baseline, 4 months, 8 months |
| Health Distress | Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaged the items; with higher values indicating more health distress. Possible range is 0 to 5. | Baseline, 4 months, 8 months |
| Well-being | Well-being was measured using the 5-items World Health Organization (WHO) Well-Being Index. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating better well-being. Possible range is 0 to 25. | Baseline, 4 months, 8 months |
| Loneliness | Loneliness was measured using the 5-item NIH Toolbox Social Relationship Scale Loneliness. The items asked participants to answer regarding the past month. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more Loneliness. Possible range is 20 to 80. | Baseline, 4 months, 8 months |
| Irritability | Irritability was measured using the 5-item Brief Irritability Test. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating more irritability. Possible range is 5 to 30. | Baseline, 4 months, 8 months |
| Communication With Physicians | Communication with physicians was measured using the 3-item Lorig Communication with Physicians. The items asked participants to answer regarding the past 4 months. The measure was scored by averaging the items; with higher values indicating better communication with the healthcare provider. Possible range is 0 to 5. | Baseline, 4 months, 8 months |
| BG002 | ElderTree on Smart System (ET- SS) | Participants will receive ElderTree on a smart system. ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of chronic conditions | Number of chronic conditions was reported by participants from a list of 17 chronic conditions: chronic pain, COPD, asthma, diabetes, high cholesterol, high blood pressure, ischemic heart disease (coronary heart or coronary artery disease), atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, and dizziness/falls/loss of vestibular function. | Mean | Standard Deviation | chronic conditions |
|
Participants will receive ElderTree on a laptop. ElderTree on laptop (ET- LT): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. |
| OG002 | ElderTree on Smart System (ET- SS) | Participants will receive ElderTree on a smart system. ElderTree on smart system (ET- SS): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. |
|
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| Primary | Change in PROMIS Short Form v2.1 - Psychosocial Quality of Life Score | Psychosocial quality of life was measured using the 12-item subscale from the PROMIS 29. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating better quality of life. The possible range is 21.2 to 67.6. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| Secondary | ElderTree Days of Use | Days of ElderTree use within a 4 month period before their survey date. The possible range for days of ElderTree use is 0 to 120. | The control group did not use ElderTree, all participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | Days | baseline to 4 months, and 4 months to 8 months |
|
|
|
| Secondary | Physical Quality of Life | Physical quality of life was measured using the 12-item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The items asked participants to answer regarding the past 7 days. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more physical quality of life. The possible range is 16.2-67.7. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
|
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| Secondary | Pain Intensity | Pain intensity was measured using a single item subscale from the PROMIS 29 (Patient-Reported Outcomes Measurement Information System) Global Health. The item asked participants to answer regarding the past 7 days. The raw score of the item was used (range: 0-10); with higher values indicating more pain intensity. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 months, 8 months |
|
|
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| Secondary | Number of Participants Readmitted Within 30-days | 30-day readmissions were measured using a single item asking participants to answer regarding the past 4 months. The raw score, answering yes/no to having a 30-day readmission, was used. Those participants answering 'yes' to being readmitted in the last 30 days are reported for each time point. | All participants did not return surveys at 4 and 8 month time points. | Posted | Count of Participants | Participants | Baseline, 4 months, 8 months |
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| Secondary | Health Distress | Health distress was measured using the 4-item Lorig Health Distress Scale. The items asked participants to answer regarding the past month. The measure was scored by averaged the items; with higher values indicating more health distress. Possible range is 0 to 5. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| Secondary | Well-being | Well-being was measured using the 5-items World Health Organization (WHO) Well-Being Index. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating better well-being. Possible range is 0 to 25. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| Secondary | Loneliness | Loneliness was measured using the 5-item NIH Toolbox Social Relationship Scale Loneliness. The items asked participants to answer regarding the past month. Scoring of individual items varies and is calculated by the scale's developers; with higher values indicating more Loneliness. Possible range is 20 to 80. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| Secondary | Irritability | Irritability was measured using the 5-item Brief Irritability Test. The items asked participants to answer regarding the past 7 days. The measure was scored by summing the items; with higher values indicating more irritability. Possible range is 5 to 30. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| Secondary | Communication With Physicians | Communication with physicians was measured using the 3-item Lorig Communication with Physicians. The items asked participants to answer regarding the past 4 months. The measure was scored by averaging the items; with higher values indicating better communication with the healthcare provider. Possible range is 0 to 5. | All participants did not return surveys at 4 and 8 month time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months, 8 months |
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| 3 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | ElderTree on Laptop (ET- LT) | Participants will receive ElderTree on a laptop. ElderTree on laptop (ET- LT): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT) | 1 | 91 | 0 | 91 | 0 | 91 |
| EG002 | ElderTree on Smart System (ET- SS) | Participants will receive ElderTree on a smart system. ElderTree on smart system (ET- SS): ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health. ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ElderTree on smart system (ET- SS) will use voice-activated "smart" speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided. | 1 | 86 | 0 | 86 | 0 | 86 |
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| 4 months |
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| 8 months |
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| 4 months to 8 months |
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| 4 months |
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| 8 months |
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| 4 Months |
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| 8 Months |
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| 4 months |
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| 8 months |
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| 4 months |
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| 8 months |
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| 4 months |
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| 8 months |
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| 4 months |
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| 8 months |
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| 4 months |
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| 8 months |
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| 4 months |
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| 8 months |
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