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| ID | Type | Description | Link |
|---|---|---|---|
| R61NR020845 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This pilot randomized controlled trial (RCT) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs).
This 2-arm pilot trial randomized 30 Black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. After the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions used Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents were integrated into these sessions, which facilitated discussion of these options with their PCP. The first 3 sessions ideally took place prior to the patient's next scheduled PCP visit; the final session occurred after this visit. Assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months.
Patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they were given the DA and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching and Decision Aid | Experimental | Individual coaching sessions and Decision Aid |
|
| Control | No Intervention | Wait-list control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaching and Decision Aid | Behavioral | Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | 3 months |
| Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. | 3 months |
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Inclusion Criteria:
Eligible patients must:
Exclusion Criteria:
Patients are excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Matthias, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health Primary Care | Indianapolis | Indiana | 46254 | United States |
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| ID | Type | URL | Comment |
|---|---|---|---|
| VIV00009027 | Individual Participant Data Set | View IPD |
NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing. All HEAL Initiative award recipients, regardless of the amount of direct costs requested for any one year, are required to comply with the HEAL Public Access and Data Sharing Policy, which also aligns with the NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html). HEAL award recipients must following all requirements and timelines developed through the HEAL Initiative Data Ecosystem, as described in HEAL's compliance guidance (https://heal.nih.gov/data/complying-heal-data-sharing-policy).
At the time of publication of the primary manuscript
Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy.
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Potentially eligible participants (primary care patients within an academic, safety-net healthcare system) were identified through electronic medical records and sent a letter and brochure describing the study. A study team member followed up with a phone call to assess interest and, if interested, screen for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coaching and Decision Aid | Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents |
| FG001 | Control | Wait-list control group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3-months |
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| |||||||||||||||||||||
| 6-months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coaching and Decision Aid | Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents |
| BG001 | Control |
| 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 | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 3 Months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
approximately 6 months
Adverse events were not systematically collected for this study that was determined to be minimal risk by the Institutional Review Board.
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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 | Coaching and Decision Aid | Individual coaching sessions and Decision Aid Coaching and Decision Aid: Four (4) coaching sessions over approximately 12 weeks with integration of Decision Aid contents |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Indiana University | 317-278-3154 | mmatthia@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 14, 2024 | Mar 11, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2025 | Apr 10, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2023 | Mar 11, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. | 6 months |
| Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). | 3 months |
| Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). | 6 months |
| Change From Baseline Pain Catastrophizing Scale at 3 Months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. | 3 months |
| Change From Baseline Pain Catastrophizing Scale at 6 Months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. | 6 months |
| Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. | 3 months |
| Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. | 6 months |
| Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses. | 3 months |
| Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses. | 6 months |
| Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. | 3 months |
| Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. | 6 months |
| Change From Baseline CollaboRATE at 3 Months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. | 3 months |
| Change From Baseline CollaboRATE at 6 Months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. | 6 months |
| Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. | 3 months |
| Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. | 6 months |
| NOT COMPLETED |
|
|
Wait-list control group
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest level of education completed | Count of Participants | Participants |
|
| Current relationship status | Count of Participants | Participants |
|
| Employment status | Count of Participants | Participants |
|
| Household income | When you consider your household income from all sources (today), would you say that you are comfortable, have just enough to makes ends meet, or do not have enough to make ends meet? | Count of Participants | Participants |
|
| Pain duration | How long (months) have you had the type of pain for which you are enrolled in this study? | Mean | Standard Deviation | months |
|
|
|
| Primary | Change From Baseline Brief Pain Inventory (BPI) Interference Scale at 6 Months | The pain interference score averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 3 Months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Patient Health Questionnaire (PHQ)-8 at 6 Months | The PHQ-8 is a widely-used, validated 8-item measure of depression severity. The PHQ-8 is scored by assigning a value of 0 (not at all) to 3 (nearly every day) to each of the 8 items, with a total score ranging from 0 to 24. Higher scores indicate worse depression severity. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 3 Months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Generalized Anxiety Disorder Scale (GAD-7) at 6 Months | Anxiety will be measured with the 7 item Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is scored by assigning a value of 0 to 3 to each of the seven items, with a total score ranging from 0 to 21. The total score indicates the severity of anxiety symptoms (higher scores indicating a worse outcome). | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Pain Catastrophizing Scale at 3 Months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Pain Catastrophizing Scale at 6 Months | The Pain Catastrophizing Scale is a 13-item scale that assesses catastrophizing-a cognitive-emotional factor that predicts poor treatment response. The scale uses a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time) for each item with a total score ranging from 0 to 52. Higher scores indicate a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 3 Months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Altarum Consumer Engagement (ACE) Measure at 6 Months | Patient engagement will be measured with the 12-item Altarum Consumer Engagement (ACE) Measure, which has 3 subscales: 1) commitment to manage one's health, 2) informed choice, and 3) confidence to participate in treatment decisions. Each item is assessed on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree) with a total score ranging from 0 to 48. Higher scores indicate greater engagement. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 3 Months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses. | Posted | Mean | Standard Deviation | counts of NPTs | 3 months |
|
|
|
| Secondary | Change From Baseline Use of Nonpharmacological and Self-Care Approaches (NSCAP) at 6 Months | The NSCAP asks about 9 nonpharmacological treatment (NPT) modalities and assesses details of use such as frequency, location/source of service, and patients' judgments of effectiveness. Space is also provided for other NPTs that are used but not listed. The number of modalities for which patients answer "yes" will be summed for analyses. | Posted | Mean | Standard Deviation | counts of NPTs | 6 months |
|
|
|
| Secondary | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 3 Months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5) at 6 Months | Communication self-efficacy will be measured with this 5-item scale that measures patients' self-efficacy in obtaining medical information and getting their most important health concern discussed in a clinic visit. Higher scores indicate greater communication self-efficacy. The scale uses ratings from 0 (not at all confident) to 10 (extremely confident) for each item with a total score ranging from 0 to 50. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline CollaboRATE at 3 Months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" for each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline CollaboRATE at 6 Months | Shared decision making will be measured with CollaboRATE, a 3-item measure assessing provider effort from the patient's perspective to engage in shared-decision making during a recent appointment. The CollaboRATE scale uses a 5-point Likert scale, ranging from "No effort was made (0)" to "Every effort was made (4)" or each item with a total score ranging from 0 to 12. Higher scores indicate higher provider effort from the patient's perspective to engage in shared-decision making. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 3 Months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) for each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
| Secondary | Change From Baseline Working Alliance Inventory (WAI) Client Short Form at 6 Months | The Working Alliance Inventory (WAI) Client Short Form assesses patient-provider agreement on treatment goals, collaboration to achieve these goals, and degree of emotional bond (liking and trust) between patients and providers. The scale uses ratings from 1 (Never) to 7 (Always) or each item with a total score ranging from 12 to 84. Higher scores indicate greater alliance between patient and provider. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control: Received Decision Aid | Wait-list control group | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Control: Usual Care Without Decision Aid | Control, did not receive Decision Aid | 0 | 14 | 0 | 14 | 0 | 14 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |