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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL132054-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Texas Scottish Rite Hospital for Children | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute DVT in children.
The feasibility of an innovative intervention of a validated fitness tracker, the Fitbit, to improve adherence to a 12-week activity regimen in a pilot randomized controlled trial (RCT) will be tested in 44 subjects with first, acute, proximal lower extremity deep vein thrombosis (DVT).
The primary outcomes will consist of a) feasibility indicators determined a priori (eligibility, consent, adherence, retention) and b) estimates of effect size associated with the prescribed activity regimen, by describing within-subject change in QoL and potential biomarkers of postthrombotic syndrome (PTS) pre and post intervention in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks. |
|
| Control | Active Comparator | Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Device | The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline | Feasibility criteria for rate of study eligibility met when assessed to be ≥ 30% INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | Baseline |
| Number of Screened Subjects Who Provided Consent at Baseline | Feasibility criteria for rate of consent was assessed to be ≥ 30% at baseline INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | Baseline |
| Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) | Adherence in the physical activity group is calculated based on the number of participants who complied with the target weekly goal or activity prescription during the "active" 8-week period. | 8 weeks |
| Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | 3 months |
| Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTS Biomarkers (D-dimer) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer. | From baseline to 6 months |
| Percentage Change From Baseline in FVIII PTS Biomarker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayesha Zia, M.D | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32780844 | Derived | Hasan R, Hanna M, Zhang S, Malone K, Tong E, Salas N, Sarode R, Journeycake J, Zia A. Physical activity in children at risk of postthrombotic sequelae: a pilot randomized controlled trial. Blood Adv. 2020 Aug 11;4(15):3767-3775. doi: 10.1182/bloodadvances.2020002096. |
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111 patients were screened, of whom 40 (36%) met study eligibility criteria. Of these, 23 (57.5%) consented to participate (11 randomized to physical activity arm and 12 to education or standard care arm)
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks. Fitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen. 30-minute education session |
| FG001 | Control | Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period. 30-minute education session |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks. Fitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen. 30-minute education session |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline | Feasibility criteria for rate of study eligibility met when assessed to be ≥ 30% INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | Posted | Count of Participants | Participants | Baseline |
|
From enrollment to end of treatment at 24 months
Adverse events and serious adverse events were not collected as they were not the primary and secondary outcomes of the study.
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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 | Intervention | Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks. Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen. 30-minute education session |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ayesha Zia, MD | The University of Texas Southwestern Medical Center | 214-456-7000 | Ayesha.Zia@UTSouthwestern.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 | Mar 2, 2021 | Mar 5, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 5, 2018 | Mar 5, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| D013927 | Thrombosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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| 30-minute education session | Behavioral |
|
The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). |
| 6 months |
| Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | 9 months |
| Proportion of Subjects Who Complete Post-randomization | Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial. | Within 24 months of trial initiation |
Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII |
| From baseline to 6 month |
| Change in PTS Biomarkers (C-reactive Protein) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by inflammation marker C-reactive protein (CRP) using a latex-enhanced immunoturbidimetric assay. | From baseline to 6 month |
| Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by endogenous thrombin potential using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | From baseline to 6 month |
| Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by thrombin generation assay using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | From baseline to 6 month |
| Percent Change in Fibrinolysis Biomarker | Percent Change in Fibrinolysis Biomarker from baseline to post intervention of increased physical activity is measured by thromboelastography (TEG). TEG is often used to predict bleeding and diagnose various bleeding disorders. Lysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography. Decreased clotting ability (negative value) = better outcome Increased clotting ability (positive value)= worse outcome | From baseline to 6 month |
| Change in Quality of Life | Change in Quality of Life from baseline to post intervention of increased physical activity assessed by PedsQL instrument. It consists of structured interview with the parents and the child with 23 items divided among 4 sub-scales to assess function in 4 domains: Physical; Emotional; social; and School. Each item is a statement of a problem, which the subject rates in severity from 0-4, indicating a problem never occurs (score of 0) to almost always occurs (score of 4). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50,3=25,4=0, with higher scores indicating better health related QoL. The positive change from baseline to 6 months correspond to better quality of life. | From baseline to 6 months |
| BG001 | Control | Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period. 30-minute education session |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OW/obese | Participants were categorized to have normal weight if their BMI was between 5th and 85th, overweight for BMI between >85th-95th, and obese if BMI was ≥ 95th percentile for age and sex (Reference: Severe obesity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the American Heart Association) | Count of Participants | Participants |
|
| Clot burden at diagnosis occlusive | Clot burden was defined as completely occlusive thrombus in at least one vein segment at VTE diagnosis. | Count of Participants | Participants |
|
|
|
| Primary | Number of Screened Subjects Who Provided Consent at Baseline | Feasibility criteria for rate of consent was assessed to be ≥ 30% at baseline INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | For this specific outcome, we only assess the screened subjects who met the eligibility criteria are included in this cohort. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) | Adherence in the physical activity group is calculated based on the number of participants who complied with the target weekly goal or activity prescription during the "active" 8-week period. | Posted | Mean | Standard Deviation | number of participants | 8 weeks |
|
|
|
| Primary | Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Primary | Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | Participants who submitted the questionnaire were included. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Primary | Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | Participants who submitted the questionnaire were included. | Posted | Mean | Standard Deviation | score on a scale | 9 months |
|
|
|
| Primary | Proportion of Subjects Who Complete Post-randomization | Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Count of Participants | Participants | Within 24 months of trial initiation |
|
|
|
| Secondary | Change in PTS Biomarkers (D-dimer) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | µg/mL | From baseline to 6 months |
|
|
|
| Secondary | Percentage Change From Baseline in FVIII PTS Biomarker | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII | Posted | Mean | Standard Deviation | percent change | From baseline to 6 month |
|
|
|
| Secondary | Change in PTS Biomarkers (C-reactive Protein) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by inflammation marker C-reactive protein (CRP) using a latex-enhanced immunoturbidimetric assay. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | mg/dL | From baseline to 6 month |
|
|
|
| Secondary | Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by endogenous thrombin potential using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | nM*min | From baseline to 6 month |
|
|
|
| Secondary | Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by thrombin generation assay using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | nmol/L | From baseline to 6 month |
|
|
|
| Secondary | Percent Change in Fibrinolysis Biomarker | Percent Change in Fibrinolysis Biomarker from baseline to post intervention of increased physical activity is measured by thromboelastography (TEG). TEG is often used to predict bleeding and diagnose various bleeding disorders. Lysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography. Decreased clotting ability (negative value) = better outcome Increased clotting ability (positive value)= worse outcome | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | percent amplitude change | From baseline to 6 month |
|
|
|
| Secondary | Change in Quality of Life | Change in Quality of Life from baseline to post intervention of increased physical activity assessed by PedsQL instrument. It consists of structured interview with the parents and the child with 23 items divided among 4 sub-scales to assess function in 4 domains: Physical; Emotional; social; and School. Each item is a statement of a problem, which the subject rates in severity from 0-4, indicating a problem never occurs (score of 0) to almost always occurs (score of 4). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50,3=25,4=0, with higher scores indicating better health related QoL. The positive change from baseline to 6 months correspond to better quality of life. | For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 6 months |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Control | Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period. 30-minute education session | 0 | 12 | 0 | 12 | 0 | 12 |
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| D013923 |
| Thromboembolism |
| D001519 | Behavior |