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This research will contribute to therapeutic technology to support bereaved parents who have experienced a perinatal loss. The proposed mobile application would accomplish this objective by providing a series of therapeutic modules to provide parents with tools to normalize their grief and additional coping skills to support the grieving process.
The investigators will develop grief processing and healing activities for bereaved parents, via an iterative formative development process with stakeholder input. The investigators will embed the core intervention components in administrative, provider, and client interfaces which will comprise the prototype Walk with Me (WWM) intervention.
The investigators will evaluate its feasibility and initial efficacy of WWM in a within-subjects pre-post design study. The investigators will provide the mobile-based provider component for use by health care professionals (HCPs) who work in the partner hospital. HCPs will have access to training videos and bereaved parent content. After training, the HCPs will recruit 52 bereaved parents.
HCPs will obtain consent from bereaved parents who express interest in the study to share their contact information with the research team. Parents who wish to participate will provide consent for their own participation in the study. After consent, parents will complete the baseline survey via the Qualtrics online assessment form and then be provided download access to the WWM prototype. At 4 and 8 weeks, parents will be administered post-treatment surveys. This design will allow the investigators to evaluate baseline to follow-up change in the proposed study outcomes and acceptability of the prototype WWM program.
Baseline and post-treatment surveys will measure bereaved parents traumatic stress, grief intensity, grief, grief management self-efficacy, and care experiences. The post-survey questionnaire will contain measures of usability, as well as any difficulties experienced or problems made worse. Demographics will be collected at the baseline assessment. Project staff will follow-up with parents as needed to encourage survey completion in a timely manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PeriGrief | Experimental | A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walk with Me | Behavioral | Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. |
| Measure | Description | Time Frame |
|---|---|---|
| Traumatic Stress - Intrusion Subscale | Impact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Traumatic Stress - Avoidance Subscale | Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Traumatic Stress - Hyperarousal Subscale | Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Grief Intensity - Reality Subscale |
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Inclusions Criteria
Focus Groups and Usability Testing (Bereaved Parents)
Efficacy Study (Bereaved Parents)
Exclusion Criteria
* Non-English speakers are excluded. The WWM program will first be developed in English and its feasibility established.
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| Name | Affiliation | Role |
|---|---|---|
| Camille C Cioffi, PhD | Oregon Research Behavioral Intervention Strategies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Research Behavioral Intervention Strategies, Inc. | Springfield | Oregon | 97477 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PeriGrief | A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Walk with Me: Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PeriGrief | A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Walk with Me: Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. |
| 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 | Traumatic Stress - Intrusion Subscale | Impact of Event Scale-Revised (IES-R) includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
Adverse event data was collected from completion of consent form through the final 8-week assessment period.
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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 | PeriGrief | A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Walk with Me: Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Smith | Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations | 541-484-2123 | david.smith@influetnsin.com |
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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 | Jun 1, 2021 | Jul 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2021 | Jul 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016138 | Walking |
| ID | Term |
|---|---|
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. |
| Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Grief Intensity - Congruence Subscale | The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Grief Intensity - Ability to Confront Others Subscale | The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Grief Management Self-efficacy | Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Negative Attitudes on Personal Grief | 6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale | 11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Difficulties in Emotional Regulation - Lack of Emotional Response Subscale | 11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions. | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
| Usability | The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable. | Post-Treatment (8 weeks post loss) |
| Acceptability | Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability. | Post-Treatment (8 weeks post loss) |
| Program Use - Days Using the Program | Program metrics on the backend of the program were used to track the total number of days the program was used. | Access to the program through through the study completion which was on average 2-months. |
| Program Use - Modules Completed | Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules. | Access to the program through through the study completion which was on average 2-months. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Relationship Status | Count of Participants | Participants |
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| Number of times pregnant | Count of Participants | Participants |
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| Type of loss experienced - Chemical Pregnancy (i.e., loss before the 5th week) | Count of Participants | Participants |
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| Type of loss experienced - Miscarriage in the first trimester | Count of Participants | Participants |
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| Type of loss experienced - Neonatal loss | Count of Participants | Participants |
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| Type of loss experienced - Stillbirth | Count of Participants | Participants |
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| Type of loss experienced - Termination due to fetal abnormality/viability | Count of Participants | Participants |
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| Type of loss experienced - Tubal or ectopic pregnancy | Count of Participants | Participants |
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| Type of loss experienced - Tubal or ectopic pregnancy | Count of Participants | Participants |
|
| PeriGrief |
A brief four-module intervention delivered via computer or mobile device. Modules utilize mindfulness and cognitive behavioral therapy strategies to reduce distress following perinatal loss. Walk with Me: Walk with Me is a perinatal grief mobile application to provide supportive care to bereaved parents. The application includes modules to guide bereaved parents through strategies to help support them through their grieving. |
|
|
|
| Primary | Traumatic Stress - Avoidance Subscale | Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
|
|
|
| Primary | Traumatic Stress - Hyperarousal Subscale | Impact of Event Scale-Revised includes 22 items on the past 7 days that represent symptoms of distress self-rated on a five-point scale: 0 indicates that the symptom occurs "not at all"; 1, "a little bit"; 2, "moderately"; 3, "quite a bit"; and 4, "extremely." Participants will be instructed to relate the IES-R items specifically to the loss of their child. Three scale scores are computed including intrusions (8 items), avoidance (8 items) and hyperarousal (6 items). Each subscale ranges from 0 to 4 with higher scores indicating greater levels of distress/trauma. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
|
|
|
| Primary | Grief Intensity - Reality Subscale | The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
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|
|
| Primary | Grief Intensity - Congruence Subscale | The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
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|
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| Primary | Grief Intensity - Ability to Confront Others Subscale | The Perinatal Grief Intensity Scale is 12 items that asks about an individuals' experiences with perinatal loss. Items are on a four-point scale from strongly disagree (1) to strongly agree (4). Three mean scale scores are computed including reality (5 items), congruence (4 items), and ability to confront others (2 items). Scores can range from 1 to 4 and higher scores indicate greater levels of grief intensity. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
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| Primary | Grief Management Self-efficacy | Three items that rate the bereaved parents' confidence in their ability to cope with grief, use knowledge of mindfulness skills to cope, and engage in positive behaviors to help coping. Scores are on a six-point scale (1 to 6) with a mean total score that ranges from 1 to 6. Higher scores indicate greater self-efficacy. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
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|
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| Primary | Negative Attitudes on Personal Grief | 6 items of experiences of care at the time of loss and follow-up appointments after loss. Responses on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree) to indicate level of agreement. A means score was computed and could range from 1 to 4. Higher scores indicate more negative experiences. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
|
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|
|
| Primary | Difficulties in Emotional Regulation - Nonacceptance of Emotional Response Subscale | 11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
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| Primary | Difficulties in Emotional Regulation - Lack of Emotional Response Subscale | 11 items from the Difficulties in Emotional Regulation Scale (DERS) were assessed using a response option that ranged from 1 (almost never) to 5 (almost always). Two mean scale scores were computed including nonacceptance of emotional response (6 items) and lack of emotional awareness (5 items). Scale score could range from 1 to 5 with higher scores indicating greater difficulty regulating emotions. | There were 52 participants with pretest data, 48 with 4-weeks data, and 44 is 8-weeks data. Trajectories were estimated using maximum likelihood and thus, any participant with at least one data point was included in the analyses. Thus, all 52 participants were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline (immediately following loss), 4 weeks and 8 weeks post loss |
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| Primary | Usability | The System Usability Scale is commonly used 10-item scale that measures subjective perceptions of usability on a 5-point Likert-scale. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Higher scores indicate the technology is more usable. | Posted | Mean | Standard Deviation | units on a scale | Post-Treatment (8 weeks post loss) |
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| Primary | Acceptability | Developed as part of the current study, 7 items were designed to measure the degree, on a 5-point Likert-type scale (1 = strongly or somewhat disagree, 5 = strongly or somewhat agree) to which parents found the program helpful, acceptable, and suited to their needs. A mean score was computed across all items and could range from 1 to 5. Higher scores indicate greater acceptability. | Posted | Mean | Standard Deviation | units on a scale | Post-Treatment (8 weeks post loss) |
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| Primary | Program Use - Days Using the Program | Program metrics on the backend of the program were used to track the total number of days the program was used. | Posted | Mean | Standard Deviation | days | Access to the program through through the study completion which was on average 2-months. |
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| Primary | Program Use - Modules Completed | Program metrics on the backend of the program were used to track the the total number of modules completed out of the 6 modules. | Posted | Count of Participants | Participants | Access to the program through through the study completion which was on average 2-months. |
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| 52 |
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| 52 |
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| 52 |
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| D015444 | Exercise |
| D009043 | Motor Activity |
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| 8-weeks |
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| 8-weeks |
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| 8-weeks |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| 8-weeks |
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| 8 weeks |
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| 8-weeks |
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| Completed three modules |
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| Completed four modules |
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| Completed five modules |
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| Completed all six modules |
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