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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL140492 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.
This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with < 20% drop out rates by the end of the study and that > 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training (MT) | Experimental | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training (MT) | Behavioral | Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Rate | Percentage of participants retained in the study (n enrolled/n retained X 100) | 3 months, 6 months |
| Intervention Acceptability | Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Medication Adherence | The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence. | baseline, 3 months, 6 months |
| Objectively-assessed Medication Adherence |
| Measure | Description | Time Frame |
|---|---|---|
| The Flanker Inhibitory Control and Attention Test | Cognitive function was assessed using the NIH Toolbox Fluid Cognition Battery. Each neurocognitive test was independently completed by study participants (3-5 minutes each) using a study tablet after a baseline practice trial. For each cognitive measure we report age-adjusted scores, which are automatically generated by the NIH Toolbox software. For all measures, higher scores indicate better cognitive performance. The Flanker Inhibitory Control and Attention Test is a measure of executive function, attention and inhibitory control. Participants are instructed to focus on a stimulus while inhibiting attention to another stimulus (arrows). Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent) over 20 trials. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Salmoirago-Blotcher, MD, PhD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34099424 | Background | Salmoirago-Blotcher E. A treatment in search of a disease? Challenges in mindfulness research and practice. Explore (NY). 2022 Sep-Oct;18(5):509-514. doi: 10.1016/j.explore.2021.05.005. Epub 2021 May 26. | |
| Result | Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsinger S, Levine D, Breault C, Wu JR, Bock B, Cohen R. Exploring effects of mindfulness training on medication adherence in patients with heart failure: THE MIND YOUR HEART STUDY. Annals of Behavioral Medicine. 2021; 55: S210-S210. | ||
| Result | Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Levine D, Breault C, Wu JR, and Cohen R.Effects Of Mindfulness Training On Cognitive Function And Interoceptive Awareness In Heart Failure Outpatients. Circulation 2021;144:A9159-A9159. | ||
| 35067596 |
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Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. De-identified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be de-identified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
Once the main findings from the final research data set have been accepted for publication.
Researchers interested in obtaining the de-identified data and associated documentation (e.g. codebook) can make a request to the principal investigator by email.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants were instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| 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 | Retention Rate | Percentage of participants retained in the study (n enrolled/n retained X 100) | 1 participant withdrew from the study and 1 died before the intervention started; these participants were not include in final analyses. | Posted | Count of Participants | Participants | 3 months, 6 months |
|
6 months
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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 | Mindfulness Training (MT) | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Mindfulness Training (MT): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sudden cardiac death | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| influenza | Infections and infestations | Non-systematic Assessment |
This study did not accrue the planned number of participants (n=50) due the to Covid-19 pandemic leading to a smaller than planned sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Salmoirago-Blotcher | The Miriam Hospital | 401-793-8325 | Elena_Salmoirago_Blotcher@brown.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 | Apr 10, 2020 | Aug 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2019 | Aug 3, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
Medication Event Monitoring Systems (MEMS). Proportion of medication taken/medication prescribed x 100, averaged over 30 days. Range is 0-100%. Lower values indicate worse adherence.
| baseline, 3 months, 6 months |
| Functional Capacity | 6-min walk test (6MWT) distance. The 6 min walk test measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters. | baseline, 3 months, 6 months |
| baseline, 3 months, 6 months |
| The Dimensional Change Card Sort Test | The Dimensional Change Card Sort Test is a measure of cognitive flexibility and attention. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The relevant dimension for sorting is indicated by a cue word (e.g., "shape" or "color") that appears on the screen for all participants. Age-adjusted scores are calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | Baseline, 3 months, 6 months |
| Oral Symbol Digit Test | The Oral Symbol digit test is a measure of working memory and processing speed. A key with nine abstract symbols is presented - each paired with a number between 1 and 9. Participants are asked to verbally indicate which numbers go with the symbols that are presented in a long string on the computer screen. The participant is given 120 seconds to call out as many numbers that go with the corresponding symbols as he/she can - in order, without skipping any. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | baseline, 3 months, 6 months |
| Picture Sequence Memory Test | The Picture Sequence Memory Test is a measure of episodic memory. Sequences of pictured objects and activities are presented in a particular order. The participants are asked to reproduce the sequence of pictures that is shown on the screen. Participants respond by dragging pictures from the yellow box on the screen into the gray boxes on the screen. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | baseline, 3 months, 6 months |
| List Sorting Working Memory Test | The List Sorting Working Memory Test is a measure of working memory. Pictures of foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods) and then on two dimensions (foods, then animals). Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | baseline, 3 months, 6 months |
| Depressive Symptoms | Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity. | baseline, 3 months, 6 months |
| Sleep Quality | Pittsburgh Sleep Quality Index. Self-report measure of sleep quality and quantity. Higher scores indicate better sleep quality and quantity. The overall score range is 0-21. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Noticing Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the noticing subscale score was 0-20. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Not Distracting Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not distracting subscale score was 0-15. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Not Worrying Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not-worrying subscale was 0-15. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Attention Regulation Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the attention regulation subscale score was 0-35. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Emotional Awareness Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the emotional awareness score was 0-25. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Self-regulation Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the self-regulation score was 0-20. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Body Listening Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the body listening score was 0-15. | baseline, 3 months, 6 months |
| Interoceptive Awareness: Trusting Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the trusting subscale score was 0-15. | baseline, 3 months, 6 months |
| Result |
| Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Breault C, Levine D, Wu JR, Cohen R. Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):595-602. doi: 10.1097/JCN.0000000000000891. Epub 2022 Jan 24. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Intervention Acceptability | Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5). | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Self-reported Medication Adherence | The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Secondary | Objectively-assessed Medication Adherence | Medication Event Monitoring Systems (MEMS). Proportion of medication taken/medication prescribed x 100, averaged over 30 days. Range is 0-100%. Lower values indicate worse adherence. | Posted | Mean | Standard Deviation | percentage of meds taken/prescrib | baseline, 3 months, 6 months |
|
|
|
| Secondary | Functional Capacity | 6-min walk test (6MWT) distance. The 6 min walk test measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters. | Posted | Mean | Standard Deviation | meters | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | The Flanker Inhibitory Control and Attention Test | Cognitive function was assessed using the NIH Toolbox Fluid Cognition Battery. Each neurocognitive test was independently completed by study participants (3-5 minutes each) using a study tablet after a baseline practice trial. For each cognitive measure we report age-adjusted scores, which are automatically generated by the NIH Toolbox software. For all measures, higher scores indicate better cognitive performance. The Flanker Inhibitory Control and Attention Test is a measure of executive function, attention and inhibitory control. Participants are instructed to focus on a stimulus while inhibiting attention to another stimulus (arrows). Sometimes the middle stimulus points in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent) over 20 trials. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | The Dimensional Change Card Sort Test | The Dimensional Change Card Sort Test is a measure of cognitive flexibility and attention. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape). The relevant dimension for sorting is indicated by a cue word (e.g., "shape" or "color") that appears on the screen for all participants. Age-adjusted scores are calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | Oral Symbol Digit Test | The Oral Symbol digit test is a measure of working memory and processing speed. A key with nine abstract symbols is presented - each paired with a number between 1 and 9. Participants are asked to verbally indicate which numbers go with the symbols that are presented in a long string on the computer screen. The participant is given 120 seconds to call out as many numbers that go with the corresponding symbols as he/she can - in order, without skipping any. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | Picture Sequence Memory Test | The Picture Sequence Memory Test is a measure of episodic memory. Sequences of pictured objects and activities are presented in a particular order. The participants are asked to reproduce the sequence of pictures that is shown on the screen. Participants respond by dragging pictures from the yellow box on the screen into the gray boxes on the screen. Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | List Sorting Working Memory Test | The List Sorting Working Memory Test is a measure of working memory. Pictures of foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods) and then on two dimensions (foods, then animals). Age-adjusted scores were calculated automatically by the NIH Toolbox software. Higher scores indicate better function. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
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| Other Pre-specified | Depressive Symptoms | Hospital Anxiety and Depression Scale depression scores. Score range 0-21. Higher scores indicate greater psychological morbidity. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
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| Other Pre-specified | Sleep Quality | Pittsburgh Sleep Quality Index. Self-report measure of sleep quality and quantity. Higher scores indicate better sleep quality and quantity. The overall score range is 0-21. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | Interoceptive Awareness: Noticing Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the noticing subscale score was 0-20. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
|
| Other Pre-specified | Interoceptive Awareness: Not Distracting Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not distracting subscale score was 0-15. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
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| Other Pre-specified | Interoceptive Awareness: Not Worrying Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the not-worrying subscale was 0-15. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
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| Other Pre-specified | Interoceptive Awareness: Attention Regulation Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the attention regulation subscale score was 0-35. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
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| Other Pre-specified | Interoceptive Awareness: Emotional Awareness Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the emotional awareness score was 0-25. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
|
|
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| Other Pre-specified | Interoceptive Awareness: Self-regulation Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the self-regulation score was 0-20. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
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| Other Pre-specified | Interoceptive Awareness: Body Listening Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the body listening score was 0-15. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
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| Other Pre-specified | Interoceptive Awareness: Trusting Score | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. For each subscale, items were summed; higher scores indicate higher levels of interoceptive awareness. This instrument has adequate to excellent internal-consistency reliability, with Cronbach's alphas between 0.66 and 0.87, and > 0.70 for five of the eight scales. The theoretical range for the trusting subscale score was 0-15. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months |
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|
| 2 |
| 31 |
| 3 |
| 31 |
| 8 |
| 31 |
| death | Cardiac disorders | Systematic Assessment |
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| stroke | Nervous system disorders | Systematic Assessment |
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| uncontrolled hypertension | Cardiac disorders | Non-systematic Assessment |
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| fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Impacted tooth | Surgical and medical procedures | Non-systematic Assessment |
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| pneumonia | Infections and infestations | Non-systematic Assessment |
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| car accident | Social circumstances | Non-systematic Assessment |
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| elective surgery | Surgical and medical procedures | Non-systematic Assessment |
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Not provided
Not provided
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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