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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Grant/Funding Number | Forge AHEAD |
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The purpose is to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based program, is designed to empower Black chronic kidney disease patients (CKD) and their care partners to seek the resources and support needed to be activated allies when making health-related decisions.
Participants, both caregivers and patients, completed surveys at study start and at 12 weeks of enrollment. Patients only, based on random assignment, then completed either 1, 3, or 4 education sessions via telehealth or audio connection. Caregivers were not restricted from attending sessions, but were not required. Both patients and caregivers then repeated survey measures at 12 weeks of enrollment. Caregiver and patient participants also completed an interview to share their thoughts on the version of the program they recieved (patients) caregiver interviews focused on if they were able to review mateirals send to the patient, and/or if they noticed a difference in communication, information sharing, etc. after the patient compelted their session(s), and other factors of interest.
Black people with chronic kidney disease and uncontrolled high blood pressure face a higher risk of developing severe cardiovascular disease and face an additional risk of their kidney disease getting worse more quickly. Many things add to this risk, including living in areas with lower access to support resources and lower quality of communication and information sharing with medical team members. Over the past 18 months, our team has worked in partnership with a group of community advisory members, two who are living with chronic kidney disease, two who are care partners of someone with chronic kidney disease, and one who has experience as a social worker in a dialysis clinic. Together the team and the community advisory board created a program focused on teaching skills for health-related decision-making. The program consists of education on 1) communication, 2) social support usefulness, or 3) a combination of both. The team seeks to understand how these sessions, alone or together, impact how the person with chronic kidney disease makes decisions and how they feel they receive support from their care partner and/or medical team. In addtion, the team also seeks to understand if there are benefits to the person with chronic kidney disease and their care partner's quality of life and how the two work together to cope with the illness experience. The goal is to positively impact health promotion by teaching answer-seeking behaviors to people with high-risk chronic kidney disease.
The team is seeking to recruit 32 Black adults with stage 3 or 4 chronic kidney disease and one identified care partner from the University of Alabama at Birmingham (UAB) Chronic Kidney Disease Clinic and Cooper Green Primary and Kidney Specialty Care Clinic. In the study, there are four groups the dyad can be randomized to: Group 1 will participate in one session on communication, Group 2 will receive 3 sessions on social support effectiveness; and Group 3 will have both communication and social support sessions. Group 4 will not participate in the sessions at all through the 12 week timerame. Caregivers were not madated to attend sessions, but did compelte data collection, so we could understand potential impact and thus they are by proxy assigned to the same group as their patient. All groups will be asked to complete surveys and one interview about their experience three months after the program is done. After this data collection, the participants in Group 4 will be invited to participate in the session combination they choose, so they receive potential benefit from their participation. The wait-listed group will not repeat measures after they expereince sessions, the focus is fariness and desire to ensure they recieved sessions as a part of their study participation.
The education sessions were delivered to patients over video conference connection with those lacking access or the ability to connect using audio only.
The plan is to share results scientifically and in the community as a team. For community sharing the team will conduct group classes, developed from content that was shared as beneficial in the interviews at Cooper Green and the UAB Chronic Kidney Disease Clinic and in two community-based locations that the community advisory group identifies. The team, including our community advisory croup members, will also write articles to submit to science-based journals. The results of this project will be used to prepare and submit an application to receive more funding to evaluate this program with a larger group of people from other areas in the state or the country.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Communication | Experimental | Patient participants in this group completed one session of communication training and had 1 follow up call a month after the session has been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
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| Group 2 - Social Support Effectiveness | Experimental | Patient participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
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| Group 3 - Communication and Social Support Effectiveness | Experimental | Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
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| Group 4 - Wait-listed Control | Placebo Comparator | Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. After 12 week data collection, the patient will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImPart-Multi - IMproving the decisional PARTnership of Chronic Kidney Disease Dyads with concurrent metabolic disease | Behavioral | ImPart-Multi is a psychoeducational, decision support training program, designed to impact Black chronic kidney disease patients with concurrent metabolic disease and their care partners' ability to 1. contemplate the decision needed, 2. request resources/support, and 3. make an informed patient-centered decision. Participants will participate in either communication training, social support effectiveness training, or a combination of both. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability Interviews (Investigator Developed) | Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable. | Completed at 12 week survey data collection |
| Feasibility of Intervention Measure | The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decision Conflict Scale (DCS) | The decision conflict scale is a 16-item total scale, using a 0-4 Likert scale to assess decision conflict. The total sum score was used as an indicator of overall decision conflict. The higher the number (mean), the greater the decision conflict. Total instrument scores range from 0-100. | From enrollment to end of study at 12 weeks |
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Inclusion Criteria:
Patients
Inclusion Criteria:
Care partner
Exclusion Criteria:
Patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shena Gazaway, PhD | UAB School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0001 | United States |
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As a condition of enrollment, patients and caregivers completed baseline surveys. The number of participants indicates individual participant numbers, not the total number of dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Communication | Patient participants in this group completed one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver and patient participants completed data collection at study start and 12 weeks after enrollment. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 24, 2024 |
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Statistician
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| Social Support Effectiveness-Questionnaire | The Social Support Effectiveness Questionnaire is a 25-item measuring perceptions of help received in the last 3 months for patients only, on a likert scale 0-4. Total scores range from 0-80, Likert scale 0-4, with higher scores indicating greater social support. | From enrollment to end of study at 12 weeks |
| Kidney Disease Quality of Life Scale (KDQOL-36) | The KDQOL-36 is a 36-item instrument measuring 3 domains: Symptoms and problems of kidney disease, effect of kidney disease, and burden of kidney disease, using a Likert scale 1-5. All domains' total scores can range from 0 to 100. For the symptoms and problems of kidney disease scale, greater numbers indicates greater quality of life. For the effects of kidney disease, the greater the number (mean), the more the patient feels the disease and its treatment have less negative impact on their life, indicating a better quality of life in that specific area. For the burden of kideny disease subscale higher scores means a better, less burdensome quality of life | From enrollment to end of study at 12 weeks |
| PROMIS Global Health 10 | The PROMIS Global Health is a 10 items measure of global health-related quality of life in 2 domains, physical and mental health. social domains. It yields two summary scores: Global Physical Health (GPH): Reflects physical health, fatigue, pain, and ability to perform physical activities. Global Mental Health (GMH): Reflects mental health, emotional distress, and satisfaction with social activities and roles. Each item uses a 5-point Likert scale (e.g., Excellent to Poor, Never to Always). Pain is rated on a 0-10 numeric scale and recoded to a 5-point scale for scoring. Raw scores for GPH and GMH are calculated by summing four designated items for each domain. Raw scores are converted to T-scores using PROMIS scoring tables or the HealthMeasures Scoring Service. T-scores are standardized to the U.S. general population (Mean = 50, SD = 10). Higher T-scores indicate better health status. | From enrollment to end of study at 12 weeks |
| Dyadic Coping Inventory | The Dyadic Coping Inventory is a 37 item instrument designed to measure perceived communication and dyadic coping. The total score ranges from 35-175, items are scored 1-5 (rarely to ofetn). Higher scores indicated better dyadic coping: below 111 (low); 111-145 (normal); and above 145 (high). | From enrollment to end of study at 12 weeks |
| Group 2 - Social Support Effectiveness |
Patient participants in this group completed 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patient and caregiver participants compelted data collection at study start and at 12 weeks of enrollment. |
| FG002 | Group 3 - Communication and Social Support Effectiveness | Patient participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
| FG003 | Group 4 - Wait-listed Control | Patient participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. . After 12 week data collection, patients will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. There was no addtional data collection after compeletion of sessions. |
| Baseline Data Completion -Patients |
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| Baseline Data Completion - Caregivers |
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| 12 week data collection - Patient |
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| 12 week data collection - Caregivers |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Communication | Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
| BG001 | Group 2 - Social Support Effectiveness | Patient Participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
| BG002 | Group 3 - Communication and Social Support Effectiveness | Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. |
| BG003 | Group 4 - Wait-listed Control | Patient Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patients and caregivers in this group compelted data collection at baseline and 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. No additional data collection occured after recieving sessions for this group, our goal was equity. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | patients and caregivers are split apart and represented in separate rows | Count of Participants | Participants |
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| Sex: Female, Male | patients and caregivers are split apart and represented in separate rows | Count of Participants | Participants |
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| Race (NIH/OMB) | patients and caregivers are split apart and represented in separate rows | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | patients and caregivers are split apart and represented in separate rows | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 | Acceptability Interviews (Investigator Developed) | Through qualitative interviews, participants reported if ImPart-Mulit participation and trial procedures were acceptable. | Patient and caregiver participants could completed an investigator developed semi-structured interview. All did not choose to participate. For ImPart-Multi acceptable theme only patient data is represented as they are the only individuals who participated in sessions. Patients and caregivers were recruited, recieved surveys, and could give feedback on study procedures realted to implementation. Under the theme of Study Proedures Acceptable both are represented. | Posted | Count of Participants | Participants | Completed at 12 week survey data collection |
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| Primary | Feasibility of Intervention Measure | The FIM is a 4 question survey asking questions regarding how feasible it was to complete the ImPart-Multi Intervention on a 5 point likert scale (1-5). The closer the mean to 5 the greater preceived feasibiltiy. Only patients completed sessions, so only patient data is represented in this measures outcomes. The closer to 5 the mean, the more feasiable the intervention was precieved. All patients did not complete this measure. | OInly patients completed the intervention sessions thus they are the only individuals who compelted the FIM. | Posted | Mean | Standard Deviation | unites on a scale | 12 weeks |
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| Secondary | Decision Conflict Scale (DCS) | The decision conflict scale is a 16-item total scale, using a 0-4 Likert scale to assess decision conflict. The total sum score was used as an indicator of overall decision conflict. The higher the number (mean), the greater the decision conflict. Total instrument scores range from 0-100. | Only patient participants completed the Decision Conflict Scale, some patients did not complte all measures at baseline or at 12 week data collection | Posted | Mean | Standard Deviation | units on a scale | From enrollment to end of study at 12 weeks |
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| Secondary | Social Support Effectiveness-Questionnaire | The Social Support Effectiveness Questionnaire is a 25-item measuring perceptions of help received in the last 3 months for patients only, on a likert scale 0-4. Total scores range from 0-80, Likert scale 0-4, with higher scores indicating greater social support. | Patient participants were the only ones who completed this measure | Posted | Mean | Standard Deviation | units on a scale | From enrollment to end of study at 12 weeks |
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| Secondary | Kidney Disease Quality of Life Scale (KDQOL-36) | The KDQOL-36 is a 36-item instrument measuring 3 domains: Symptoms and problems of kidney disease, effect of kidney disease, and burden of kidney disease, using a Likert scale 1-5. All domains' total scores can range from 0 to 100. For the symptoms and problems of kidney disease scale, greater numbers indicates greater quality of life. For the effects of kidney disease, the greater the number (mean), the more the patient feels the disease and its treatment have less negative impact on their life, indicating a better quality of life in that specific area. For the burden of kideny disease subscale higher scores means a better, less burdensome quality of life | This measure was only collected on patient participants, all did not compete 12 week data collection. Also this is a subscaled instrument where if the answer is not appilicable directions indicate questions can be skipped. | Posted | Mean | Standard Deviation | units on a scale | From enrollment to end of study at 12 weeks |
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| Secondary | PROMIS Global Health 10 | The PROMIS Global Health is a 10 items measure of global health-related quality of life in 2 domains, physical and mental health. social domains. It yields two summary scores: Global Physical Health (GPH): Reflects physical health, fatigue, pain, and ability to perform physical activities. Global Mental Health (GMH): Reflects mental health, emotional distress, and satisfaction with social activities and roles. Each item uses a 5-point Likert scale (e.g., Excellent to Poor, Never to Always). Pain is rated on a 0-10 numeric scale and recoded to a 5-point scale for scoring. Raw scores for GPH and GMH are calculated by summing four designated items for each domain. Raw scores are converted to T-scores using PROMIS scoring tables or the HealthMeasures Scoring Service. T-scores are standardized to the U.S. general population (Mean = 50, SD = 10). Higher T-scores indicate better health status. | Caregiver participants are the only individuals who completed this measure. | Posted | Mean | Standard Deviation | T-scores (converted) | From enrollment to end of study at 12 weeks |
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| Secondary | Dyadic Coping Inventory | The Dyadic Coping Inventory is a 37 item instrument designed to measure perceived communication and dyadic coping. The total score ranges from 35-175, items are scored 1-5 (rarely to ofetn). Higher scores indicated better dyadic coping: below 111 (low); 111-145 (normal); and above 145 (high). | Not all participants completed 12 week data collection on this instrument | Posted | Mean | Standard Deviation | units on a scale | From enrollment to end of study at 12 weeks |
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From enrollment until 4 weeks post-survey (12-week data collection), to allow for receiving survey responses before interviews were scheduled, so as not to influence quantitative survey collection (thus up to 16 weeks).
Both patients and caregiver data are represented in adverse reporting. Those who were wati-listed, completed all cross over sessions before they had their interview. Thus they are not represented in any other group, but the wait-listed category, as that is how data collection was conducted.
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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) |
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| EG000 | Group 1 - Communication | Patient Participants in this group will complete one session of communication training and will have 1 follow up call a month after the session has been completed. Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Group 2 - Social Support Effectiveness | Patient Participants in this group will complete 3 sessions of social support effectiveness training. All will complete 1 follow-up call after the 3 sessions have been completed. Patient and Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Group 3 - Communication and Social Support Effectiveness | Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Patient and Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Group 4 - Wait-listed Control | Patient Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Patient and Caregiver data is also included as they completed data collection. Thus, the data presented is for both patients and caregivers. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shena Gazaway | University of Alabama at Birmingham | 2059755304 | gazaways@uab.edu |
| Oct 21, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Caregivers |
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| caregivers |
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| caregivers |
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| Study Procedures Acceptable |
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Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Only patient data is presented here.
| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. Only patient data presented here. |
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Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow-up call will be completed one month after the last session has been completed. Patient and caregiver data is presented here. .
| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again. |
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| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again. |
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| OG002 | Group 3 - Communication and Social Support Effectiveness | Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow-up call will be completed one month after the last session has been completed. Patient and caregiver data is presented here. . |
| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again. |
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| OG002 | Group 3 - Communication and Social Support Effectiveness | Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow-up call will be completed one month after the last session has been completed. Patient and caregiver data is presented here. . |
| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again. |
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Patient Participants assigned to this group will complete 4 sessions of communication and social support effectiveness training. One follow up call will be completed one month after the last session has been competed. Caregiver and patients completed data collection and both are presented here.
| OG003 | Group 4 - Wait-listed Control | Participants assigned to this group will receive no training sessions the first 12 weeks of enrollment. Data collection on patients and caregivers occurred at 12 weeks. After 12 week data collection, they will be assigned to complete either communication (1 session) or social support effectiveness (3 sessions) training. One month after the completion of the training sessions a follow-up call will be made. This measure was not collected post-crossover again. |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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