Certified Nursing Assistants' Wellbeing (CNA)

• ClinicalTrials.gov Identifier: NCT03720652
• Recruitment Status: Completed
• First Posted: October 25, 2018
• Results First Posted: April 29, 2021
• Last Update Posted: April 29, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

Certified nursing assistants (CNAs), who provide the majority of care to persons with chronic disease and/or cognitive impairment from Alzheimer's disease and related dementias, face tremendous job and home stress, and as a result absenteeism and job turnover are high. This is a preliminary study that will tailor Mindful Self-Compassion (MSC) - a promising new program designed to cultivate greater self-care, and strengthen resilience and coping skills - for the CNA population and study its effectiveness. If results are favorable, MSC could be incorporated into CNA training programs, thereby helping contribute to a more effective and stable long-term care workforce.

Condition or disease	Intervention/treatment	Phase
Stress and Burnout	Behavioral: 8-Week Mindful Self-Compassion (MSC); Behavioral: 6-Week Mindful Self-Compassion (MSC)	Not Applicable

Detailed Description:

U.S. nursing homes (NHs) serve 1.6 million older persons, all of whom have significant physical and/or cognitive impairment, and the majority of whom have Alzheimer's disease or a related cognitive disorder. In these settings the vast majority of hands-on care is provided by an estimated 634,000 certified nursing assistants (CNAs) - paraprofessional caregivers who are racially diverse, largely female, and an annual income equivalent to the poverty threshold for a family of four. Despite the crucial role of CNAs in providing care for the long-term care population and efforts to recruit and retain a stable workforce, absenteeism rates are high and annual turnover averages 65%, with adverse impact on the quality of care provided to NH residents, making CNA retention a policy priority.

CNAs have significant life stressors that affect their ability to work, such as single parenthood, poor physical health, difficulty finding childcare, and transportation problems. They also face emotionally and physically demanding job tasks, particularly when working with persons with Alzheimer's disease and related dementias, and many lack helpful strategies for dealing with stress, negative feelings, and burden.

A newly developed, standardized Mindful Self-Compassion (MSC) intervention may have particularly high impact and relevance for the high-stress lives of NH CNAs. MSC training has been shown to increase wellbeing, compassion for others, and stress-coping skills. However, little is known about the impact, feasibility and acceptability of MSC training in low-educated, stress-burdened paraprofessional populations such as CNAs, or whether it can impact outcomes such as burnout, absenteeism, and turnover.

This preliminary study will modify, refine, and test a MSC training intervention for CNAs, to be known as the CNA Wellbeing Program, who care for nursing home residents. The researcher teams' goal is to increase CNA coping skills and well-being, thereby reducing intent to leave the job, reducing burnout, and improving job satisfaction and attitudes toward people with dementia. The proposed research will be conducted in 3 similarly rated and structured community NHs. In Aim 1 the investigators will assess intervention feasibility and acceptability in one NH, using the knowledge they gain to tailor an evidence-based MSC program specifically for CNAs. In Aim 2 the investigators will pilot test the MSC training program with 30 CNAs who work in 2 similarly rated and structured NHs, evaluating the fidelity of the revised training and exploring trends in immediate, 3-month, and 6-month outcome measures in order to inform power calculations for future trials.

The specific aims are:

Aim 1. Determine the feasibility, acceptability, and necessary adaptations of MSC training needed to meet the diverse cultural background, limited literacy, and job and family challenges of the nursing home CNA workforce, including the unique challenges of caring for persons with dementia, and of the data collection methods.

1. Conduct a field trial of the standardized 8-week MSC training program with 15 CNAs within a single community NH. Evaluation will focus on: (a) participation (including home practice adherence); (b) attendee evaluation of the training; (c) barriers to and facilitators of participation; (d) use and retention of class material by participants; and (e) recommendations for improvement of training.
2. Field test the feasibility and acceptability of our study recruitment and evaluation strategy.
3. Use data collected from the field test to modify recruitment strategies, protocols, and course structure, content and materials so as to be maximally feasible, acceptable and effective in a CNA population.

Aim 2. Conduct a pilot test of the adapted protocols and intervention in a sample of 30 CNAs from 2 similarly rated and structured community NHs to reexamine feasibility and acceptability, identify trends in key intermediate and long-term outcomes, and estimate effect size in preparation for a future randomized trial.

1. Evaluate the fidelity and immediate impact of the modified training by measuring (a) training attendance; (b) satisfaction with the training; and (c) pre-and post-training measures of self-compassion, perceived stress, job satisfaction, job burnout symptoms, and attitudes towards persons with dementia.
2. Evaluate the sustained impact of the training by comparing baseline, 3-and 6-month post-training measurements of: intent to leave job, self-compassion, perceived stress, job satisfaction, job burnout symptoms, and attitudes towards persons with dementia.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

In Aim 1, the 8-week MSC program was conducted with nursing assistants from 1 nursing home to test for feasibility and practicality.

After receiving feedback from participants of Aim 1, in Aim 2, the MSC program will be conducted in 2 nursing homes. Both nursing homes in Aim 2 will receive a shortened 6-week, 1 hour version specific to health care staff, in order to test the feasibility and practicality.

• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Mindful Self-Compassion Training to Improve Retention, Job Satisfaction, and Attitudes Toward Dementia Among Long-Term Care Nursing Assistants
• Actual Study Start Date: March 27, 2019
• Actual Primary Completion Date: June 2, 2020
• Actual Study Completion Date: June 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 8-Week Mindful Self-Compassion (MSC); CNAs in Aim 1 will participate in the standardized, 8-week Mindful Self-Compassion course. Each 8-week session will last for 2.5 hours. Also included is a half day retreat, that CNAs may attend if they are able.	Behavioral: 8-Week Mindful Self-Compassion (MSC); The 8-week MSC is a course of eight 2.5 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 8-session program that integrates SC and mindfulness. It includes the following components: Discovering Mindful Self-Compassion; Practicing Mindfulness; Practicing Lovingkindness; Discovering your Compassionate Voice; Living Deeply; Meeting Difficult Emotions; Exploring Challenging Relationships; Embracing Your Life
Experimental: 6-Week Mindful Self Compassion (MSC); CNAs from both nursing homes in Aim 2 will participate in the 6-week Mindful Self-Compassion course, that was shortened and customized to fit the needs of health care staff. Each 6-week session will last for 1 hour.	Behavioral: 6-Week Mindful Self-Compassion (MSC); The 6-week MSC is a course of six 1 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 6-session program that integrates SC and mindfulness. It includes the following components: What is Self-Compassion; Practicing Self-Compassion; Discovering your Compassionate Voice; Self-Compassion and Resilience; Self-Compassion and Burnout; Going Forward This program is a shortened version of the 8-week program, specifically created for the needs of health care staff.

Outcome Measures

Primary Outcome Measures :

1. Study Participant's Self-Rating of Likelihood to Leave Job in the Coming Year Over Time [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   The researchers will assess intent to leave job by asking "How likely is it that you will leave this job in the next year? "Would you say... 1 is Not at All Likely, 2 is Somewhat Likely, 3 is Very Likely." Minimum = 1 (best value), maximum = 3 (worst value). For the primary outcome analysis, intent will be evaluated by totaling the count of participants who responded "Somewhat Likely", "Very likely", or "Not at all likely." This was collected over the course of four time frames: Baseline, End-of Intervention interview, 3-Month Follow Up Interview, and 6-Month Follow Up Interview.

Secondary Outcome Measures :

1. Change in Mean Score Over Time on Job Satisfaction Scale (JSS) [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Job satisfaction will be assessed using the 3-item Job Satisfaction scale (JSS). Responses are provided using a 7-point Likert scale measuring how satisfied respondents are with their job. Minimum score = 0 (worst value). Maximum score = 6 (best value). Range of scores from 0 to 18, with higher values indicating better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
2. Change in Mean Score Over Time on Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Approach to Dementia Questionnaire (ADQ) - Recognition of Personhood Subscale is an 11-item instrument. Responses are indicated using a 5-point Likert scale. Minimum score (worst value) = 1. Maximum score (best value) = 5. Higher values represent a better outcome (range 11-55). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
3. Change in Mean Score Over Time on Perceived Stress Scale (PSS) [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Perceived Stress Scale (PSS) 10-item version. Perceived stress is defined as the degree to which individuals find their lives "unpredictable, uncontrollable, and overloading". Responses are indicated using a 5-point Likert scale. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome (range 0 - 40). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
4. Change in Mean Score Over Time on PROMIS Depression Scale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   PROMIS Emotional Distress Depression - Short Form (PROMIS) is an 8-item instrument. Responses are indicated using a 5-point Likert scale. Minimum score (best value) = 1/Never. Maximum score (worst value) = 5/Always. Lower values represent a better outcome (range 8-40). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
5. Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Depersonalization Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Depersonalization Subscale (one of three subscales within the MBI), a 5-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (best value, never) = 0. Maximum score (worst value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with lower values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
6. Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Emotional Exhaustion Subscale [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Emotional Exhaustion Subscale (one of three subscales within the MBI), a 8-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (best value, never) = 0. Maximum score (worst value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with lower values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
7. Change in Mean Score Over Time on Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   Burnout will be assessed via a modified Maslach Burnout Inventory (MBI) - Personal Accomplishment Subscale (one of three subscales within the MBI), a 7-item scale. Items are measured on a 7-point Likert scale that asks how often respondents are feeling certain feelings. Minimum score (worst value, never) = 0. Maximum score (best value, every day) = 6. Analysis reports mean score rather than total score; range of the mean score is 0 to 6, with higher values representing better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
8. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) [ Time Frame: Participants will be followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF), a 12-item scale that includes the three components of self-compassion: self-kindness, common humanity, and mindfulness. This is done using a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value). Analysis reports mean score rather than total score (total range is 0.0 to 5.0), with higher values indicating better outcomes. Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
9. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Self-kindness Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
   The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Self-kindness Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
10. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Self-judgment Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
    The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Self-judgment Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
11. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Common Humanity Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
    The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Common humanity Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), with higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
12. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Isolation Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
    The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Isolation Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
13. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Mindfulness Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
    The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Mindfulness Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (worst value). Maximum score = 5 (best value), with higher scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
14. Change in Mean Score Over Time on Self-compassion Scale-Short Form (SCS-SF) - Over-identification Subscale [ Time Frame: Participants were followed for the duration of the intervention and 6 additional months after the intervention ends, an expected average of 8 months ]
    The researchers will collect pre-post measures using the Self-compassion scale-short form (SCS-SF) - Over-identification Subscale (one of six subscales within the SCS-SF), a 3-item scale. Items are measured on a 5-point Likert scale. Minimum score = 1 (best value). Maximum score = 5 (worst value), with lower scores indicating better outcomes. Analysis reports mean score rather than total score (total range is 0.0 to 5.0). Measure was assessed at Baseline, at an End-of-Intervention Interview, a 3-month Follow Up Interview and at a 6-month Follow Up Interview.
15. Percent of Classes Attended by Participating CNAs [ Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks ]
    This will be reported as percent of classes attended by CNAs.
16. Percent of Participants Attending All Intervention Sessions [ Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks ]
    This will be reported by percent of participants who attended every assigned intervention session (6 or 8 depending on intervention arm).
17. Percent Intervention Minutes Attended by Participants [ Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6-8 weeks ]
    This will be collected by recording the number of minutes each participant spent per class in order to account for intervention missed due to participants' leaving early or coming late, and reporting percent of minutes attended by participants.
18. Mean Number of Days Per Week Spent in Out-of-Class Informal Exercise [ Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks ]
    Based on participant completion of weekly surveys, the researchers will measure the number of days each week that class participants were able to practice learned informal techniques and exercises outside of class hours.
19. Mean Number of Days Per Week Spent in Out-of-Class Formal Exercise [ Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6/8 weeks ]
    Based on participant completion of weekly surveys, the researchers will measure the number of days each week that class participants were able to practice learned formal techniques and exercises outside of class hours.
20. Study Participant's Self-Rating of Satisfaction With the MSC Course [ Time Frame: At the conclusion of the week 6/8 class, during the End-of-Intervention Interview, participants were asked their satisfaction with the course ]
    The researchers assess satisfaction of the MSC training using an 8-item, 5-point Likert Scale (0 = Strongly Disagree, 1 = Disagree, 2 = Neither Agree nor Disagree, 3 = Agree, 4 = Strongly Agree). Minimum = 0 (worst value), maximum = 4 (best value). Measure was assessed during the End-of-Intervention Interview.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Certified Nursing Assistant employed by one of 3 study Nursing Homes
• Aged 18 and over
• Speak English
• Work at least 20 hours as a CNA at one of our proposed Nursing Homes
• Expect to attend at least 75% of the intervention classes
• Expect to stay at least the course of the intervention on the job
• Score in the top 50% on the PSS-10 (Perceived Stress Scale) (if more than 20 participants interested)

Exclusion Criteria:

• Younger than 18
• Working fewer than 20 hours a week
• Unable to attend at least 75% of the intervention classes
• Expect to leave their position during the intervention

Contacts and Locations

Locations

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Philip D Sloane, MD, MPH; University of North Carolina, Chapel Hill

  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Study Protocol  [PDF] March 18, 2021

Statistical Analysis Plan  [PDF] March 8, 2021

More Information

Additional Information:

Nursing Home Compare 

Unscheduled Absence Survey: CCH Survey Finds Unscheduled Absenteeism Up in U.S. Workplaces. 

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• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03720652
• Other Study ID Numbers: 18-2012; 1R21AG058133-01A1 ( U.S. NIH Grant/Contract )
• First Posted: October 25, 2018
• Results First Posted: April 29, 2021
• Last Update Posted: April 29, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: The data will be shared beginning 9 to 36 months following publication, and will be available for up to 7 years post publication.
• Access Criteria: To access, interested parties will have to email Drs. Christine Lathren, lathren@email.unc.edu, and Philip D. Sloane, philip_sloane@med.unc.edu, or contact the study team through the Cecil G. Sheps Center for Health Services Research at (919) 966-5011.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

Mindfulness; Certified Nursing Assistants; Long-Term Care; Staff Turnover; Mindful Self-Compassion

Additional relevant MeSH terms:

Burnout, Psychological; Stress, Psychological; Behavioral Symptoms