Chronic PainNCT04554576
Escoge Salud (Choose Health): a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
A study testing Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish and Remote feedback active group in people with Chronic Pain, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to evaluate patient satisfaction and health status before and after a 6-week established self-management training program for middle to older age Hispanic Americans living with chronic musculoskeletal pain in a large, hospital based urban health maintenance organization. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish and Remote feedback active group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish Speaking
- Had 1 or 2 outpatient dispense records of NSAIDS between Jan 1 2018 to Dec 31 2018.
- 5 doctor office visits between 07/01/2017 - 12/31/2018 for any health program.
- Non-malignant musculoskeletal pain for at least 6 months
- Interested in learning self-management
- Ability to have telephone/video visit every 6 weeks
- Ability to travel to medical center 1x/week for 6 weeks in the afternoon for 2.5 hours
Who cannot join
- Major psychiatric or substance abuse problem
- Mild cognitive impairment/dementia
- Malignant pain or terminal illness
- Listed in the Non-contact database
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Escoge Salud (Choose Health) Effects and Sustainability of a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
The purpose of this study is to evaluate patient satisfaction and health status before and after a 6-week established self-management training program for middle to older age Hispanic Americans living with chronic musculoskeletal pain in a large, hospital based urban health maintenance organization. The secondary aim is to evaluate the effects of remote, nonfrequent healthcare provider feedback for 6 months on health care utilization, health status and patient satisfaction.
Read the detailed description
Managing chronic pain in the US costs approximately $635 billion and half of this expenditure is for joint and arthritis related pain syndromes. Interestingly, compared with non-Hispanic whites (NHWs), Hispanic Americans (HAs) report significantly lower rates of chronic pain with consistently higher levels of pain intensity in both population and clinically based studies. Chronic musculoskeletal pain (CMP) incidence increases with age and the HA aging population is among the fastest growing segments of the US population. Despite reporting more intense pain, HA are less likely to seek medical care versus NHWs for acute and chronic pain. Lack of access, cultural stoicism and an external locust of control are thought to explain why HAs seek care at a reduced rate. Psychological factors play a significant role in pain experience, HAs may employ catastrophic thinking and experience more pain related anxiety which are predictors of exacerbated pain experience. Pain comorbidities may be amenable to treatment with appropriate, culturally sensitive treatment focusing on enhancing self-efficacy to manage the complex array of psychological pain comorbidities. There is a societal impact of undertreating chronic pain in the HA population. While HAs have the lowest rate of short-term sick usage (<1-2 days), they have the highest rate of long-term sick usage (>31 days). This increased long-term time off puts HAs at risk of losing their job if the time off exceeds Family Leave and Medical Act minimums. Lastly, it is well documented, HAs are hesitant to take strong pain medication and there is conflicting evidence surrounding taking over-the-counter medications for pain management. There is a need to provide culturally sensitive, effective chronic pain management treatments for HAs.
There have been 5 well designed studies (n=931) demonstrating efficacy of a trans-created Spanish version of the Chronic Disease Self-Management Program (CDSMP) for HAs with chronic musculoskeletal pain. CDSMP has demonstrated effectiveness in improving pain intensity, self-efficacy (SE) and health behaviors in a community setting . The intervention is a healthcare provider and/or peer led 2.5 hour self-management training session, 1 time per week for 6 weeks taught in a group setting in Spanish. The program is grounded in Bandura's Social Cognitive Theory and uses goal setting and problem solving as corner stones to create a personalized self-management program. Improvements post-intervention in SE predict sustainability of health behaviors and maintenance of improved health status in the long term. Additionally, remote non-frequent health care provider feedback has been associated with maintenance of health behaviors, however this his not been tested in the HA population.
The purpose of this study is to test the feasibility (patient satisfaction and change in health status) after bringing the CDSMP programming to a large urban hospital based medical center that does not currently offer a culturally sensitive, self-management training program in Spanish middle to older age HAs with chronic pain. The secondary aim is to pilot the effectiveness of an every 6th week phone/video visit feedback visit for 24 months on both health status and healthcare utilization.
- Conditions
- Chronic Pain
- Being tested
- Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish, Remote feedback active group, Remote feedback control group
- Keywords
- Hispanic American, Latino, self-management training, sustainability, health care utilization
- Medical subject headings
- Chronic Pain, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-Management Program (CDSMP) for chronic pain in SpanishBehavioural
Also called CDSMP for chronic pain in Spanish
The CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears.
Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan.
The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain)
Remote feedback active groupBehavioural
After the 6-week self management program, half the participants will be randomized to an every 6 weeks for 6 months phone or video visit from a health care provider, in Spanish. The phone or video sessions will include: review previous action-plans (goals) and provide support in forming new action-plans (goals)
Remote feedback control groupBehavioural
After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 6-week self-management and remote feedback for 6 months | Experimental | All participants will receive the 6-week self-management program and after, half the group will be randomized to an every 6th week healthcare provider feedback phone or video visit session for 6 months (4 visits over 24 months). Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish; Behavioral: Remote feedback active group |
| 6-week self-management and control group for 6 months | Active comparator | All participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup Receives: Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish; Behavioral: Remote feedback control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Efficacy
Spanish Arthritis self-efficacy scale (ASES). This tool has 8 questions rating 'certainty' in ability to manage health and chronic pain. It is scored on a visual analogue scale from 1-10, 1= very uncertain to 10= very certain. Higher scores indicate more self-efficacy.
Measured: baseline to 6-weeks
Patient Reported Outcome Measurement Information System (PROMIS) Global Health
Spanish PROMIS Global Health v1.2 measures global physical, mental and social health. It has 10 questions, 9 of which are answered on a 5-point Likert scale and 1 question on a visual analogue scale where 0=no pain and 10=worst pain imaginable. PROMIS measures are scored on a t-score metric where 50 is set to be the population norm and higher scores indicate better global health.
Measured: baseline to 6-weeks
Pain Catastrophizing
Spanish Pain Catastrophizing Scale (PCS) evaluates 3 distinct phenomenon which are characterized by feelings of helplessness, active rumination and excessive magnification associated with pain experience. The questionnaire has 13 questions and is scored on a 5-point Likert scale, 0= not at all to 4 = all the time. Higher scores indicate more catastrophizing.
Measured: baseline to 6-weeks
Health Distress
Health Distress Scale evaluates distress and worry due to illness. It has 4 question that are answered on a 5-point Likert scale where 0= none of the time and 5= all of the time. Higher scores indicate more distress and worry.
Measured: baseline to 6-weeks
Patient Satisfaction
Adapted from Camino con Gusto study. 3 questions on satisfaction with the intervention scored on scored on a 4-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree.
Measured: baseline to 6-weeks
Patient Global Impression
Patient Global Impression of Change (PGIC) captures the patients satisfaction with the intervention by asking "How satisfied or dissatisfied are you with the self-management program?' and is scored on a 7-point scale where 7-point scale where -3 =very dissatisfied 0= neither satisfied or dissatisfied and 3= very satisfied.
Measured: baseline to 6-weeks
Secondary outcomes (6)
Doctors office visits
Number of Primary Care doctors office visits
Measured: 6 weeks to 30-34 weeks
Emergency Room use
Number of Emergency Room visits
Measured: 6 weeks to 30-34 weeks
Self Efficacy
Spanish Arthritis self-efficacy scale (ASES). This tool has 8 questions rating 'certainty' in ability to manage health and chronic pain. It is scored on a visual analogue scale from 1-10, 1= very uncertain to 10= very certain.
Measured: 6-weeks to 30-34 weeks
PROMIS Global Health
Spanish PROMIS Global Health v1.2 measures global physical, mental and social health. It has 10 questions, 9 of which are answered on a 5-point Likert scale and 1 question on a visual analogue scale where 0=no pain and 10=worst pain imaginable.
Measured: 6-weeks to 30-34 weeks
Pain Catastrophizing
Spanish Pain Catastrophizing Scale (PCS) evaluates 3 distinct phenomenon which are characterized by feelings of helplessness, active rumination and excessive magnification associated with pain experience. The questionnaire has 13 questions and is scored on a 5-point Likert scale, 0= not at all to 4 = all the time
Measured: 6-weeks to 30-34 weeks
Health Distress
Health Distress Scale evaluates distress and worry due to illness. It has 4 question that are answered on a 5-point Likert scale where 0= none of the time and 5= all of the time
Measured: 6-weeks to 30-34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start14 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective study with a secondary randomization to a remote, nonfrequent provider feedback sustainability intervention. All participants will receive the 6-week self-management intervention and do pre/post evaluations. After the 6-week intervention, half the group will be randomized to a every 6th week for 6 months healthcare provider phone/video visit session and half will be received to no treatment control for 6 months.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Gladin, DPT, Principal investigator, senior physical therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554576
- Sponsor's protocol ID
- 1326143-3
- Status last verified
- May 2022
- First submitted
- 2 Jan 2020
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will share de-identified health status pre/post and healthcare utilization information to other investigators upon request
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escoge Salud (Choose Health) Effects and Sustainability of a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
- ClinicalTrials.gov ID
- NCT04554576
- Acronym / sponsor ID
- 1326143-3
- Conditions
- Chronic Pain
- Keywords
- Hispanic American, Latino, self-management training, sustainability, health care utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate patient satisfaction and health status before and after a 6-week established self-management training program for middle to older age Hispanic Americans living with chronic musculoskeletal pain in a large, hospital based urban health maintenance organization. The secondary aim is to evaluate the effects of remote, nonfrequent healthcare provider feedback for 6 months on health care utilization, health status and patient satisfaction.
Detailed description
Managing chronic pain in the US costs approximately $635 billion and half of this expenditure is for joint and arthritis related pain syndromes. Interestingly, compared with non-Hispanic whites (NHWs), Hispanic Americans (HAs) report significantly lower rates of chronic pain with consistently higher levels of pain intensity in both population and clinically based studies. Chronic musculoskeletal pain (CMP) incidence increases with age and the HA aging population is among the fastest growing segments of the US population. Despite reporting more intense pain, HA are less likely to seek medical care versus NHWs for acute and chronic pain. Lack of access, cultural stoicism and an external locust of control are thought to explain why HAs seek care at a reduced rate. Psychological factors play a significant role in pain experience, HAs may employ catastrophic thinking and experience more pain related anxiety which are predictors of exacerbated pain experience. Pain comorbidities may be amenable to treatment with appropriate, culturally sensitive treatment focusing on enhancing self-efficacy to manage the complex array of psychological pain comorbidities. There is a societal impact of undertreating chronic pain in the HA population. While HAs have the lowest rate of short-term sick usage (<1-2 days), they have the highest rate of long-term sick usage (>31 days). This increased long-term time off puts HAs at risk of losing their job if the time off exceeds Family Leave and Medical Act minimums. Lastly, it is well documented, HAs are hesitant to take strong pain medication and there is conflicting evidence surrounding taking over-the-counter medications for pain management. There is a need to provide culturally sensitive, effective chronic pain management treatments for HAs.
There have been 5 well designed studies (n=931) demonstrating efficacy of a trans-created Spanish version of the Chronic Disease Self-Management Program (CDSMP) for HAs with chronic musculoskeletal pain. CDSMP has demonstrated effectiveness in improving pain intensity, self-efficacy (SE) and health behaviors in a community setting . The intervention is a healthcare provider and/or peer led 2.5 hour self-management training session, 1 time per week for 6 weeks taught in a group setting in Spanish. The program is grounded in Bandura's Social Cognitive Theory and uses goal setting and problem solving as corner stones to create a personalized self-management program. Improvements post-intervention in SE predict sustainability of health behaviors and maintenance of improved health status in the long term. Additionally, remote non-frequent health care provider feedback has been associated with maintenance of health behaviors, however this his not been tested in the HA population.
The purpose of this study is to test the feasibility (patient satisfaction and change in health status) after bringing the CDSMP programming to a large urban hospital based medical center that does not currently offer a culturally sensitive, self-management training program in Spanish middle to older age HAs with chronic pain. The secondary aim is to pilot the effectiveness of an every 6th week phone/video visit feedback visit for 24 months on both health status and healthcare utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective study with a secondary randomization to a remote, nonfrequent provider feedback sustainability intervention. All participants will receive the 6-week self-management intervention and do pre/post evaluations. After the 6-week intervention, half the group will be randomized to a every 6th week for 6 months healthcare provider phone/video visit session and half will be received to no treatment control for 6 months.
| Arm | Type | Receives |
|---|---|---|
| 6-week self-management and remote feedback for 6 months | Experimental | Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish, Behavioral: Remote feedback active groupAll participants will receive the 6-week self-management program and after, half the group will be randomized to an every 6th week healthcare provider feedback phone or video visit session for 6 months (4 visits over 24 months). |
| 6-week self-management and control group for 6 months | Active comparator | Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish, Behavioral: Remote feedback control groupAll participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spanish Speaking
- Had 1 or 2 outpatient dispense records of NSAIDS between Jan 1 2018 to Dec 31 2018.
- 5 doctor office visits between 07/01/2017 - 12/31/2018 for any health program.
- Non-malignant musculoskeletal pain for at least 6 months
- Interested in learning self-management
Key exclusion criteria (4 listed)
- Major psychiatric or substance abuse problem
- Mild cognitive impairment/dementia
- Malignant pain or terminal illness
- Listed in the Non-contact database
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Disease Self-Management Program (CDSMP) for chronic pain in SpanishAlso: CDSMP for chronic pain in SpanishThe CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears. Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan. The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain) | Behavioural | 6-week self-management and control group for 6 months, 6-week self-management and remote feedback for 6 months |
| Remote feedback active groupAfter the 6-week self management program, half the participants will be randomized to an every 6 weeks for 6 months phone or video visit from a health care provider, in Spanish. The phone or video sessions will include: review previous action-plans (goals) and provide support in forming new action-plans (goals) | Behavioural | 6-week self-management and remote feedback for 6 months |
| Remote feedback control groupAfter the 6-week self-management program, half the participants will be randomized to a control group for 6 months. | Behavioural | 6-week self-management and control group for 6 months |
Primary outcome
Self Efficacy
Time frame: baseline to 6-weeks
Spanish Arthritis self-efficacy scale (ASES). This tool has 8 questions rating 'certainty' in ability to manage health and chronic pain. It is scored on a visual analogue scale from 1-10, 1= very uncertain to 10= very certain. Higher scores indicate more self-efficacy.
Patient Reported Outcome Measurement Information System (PROMIS) Global Health
Time frame: baseline to 6-weeks
Spanish PROMIS Global Health v1.2 measures global physical, mental and social health. It has 10 questions, 9 of which are answered on a 5-point Likert scale and 1 question on a visual analogue scale where 0=no pain and 10=worst pain imaginable. PROMIS measures are scored on a t-score metric where 50 is set to be the population norm and higher scores indicate better global health.
Pain Catastrophizing
Time frame: baseline to 6-weeks
Spanish Pain Catastrophizing Scale (PCS) evaluates 3 distinct phenomenon which are characterized by feelings of helplessness, active rumination and excessive magnification associated with pain experience. The questionnaire has 13 questions and is scored on a 5-point Likert scale, 0= not at all to 4 = all the time. Higher scores indicate more catastrophizing.
Health Distress
Time frame: baseline to 6-weeks
Health Distress Scale evaluates distress and worry due to illness. It has 4 question that are answered on a 5-point Likert scale where 0= none of the time and 5= all of the time. Higher scores indicate more distress and worry.
Patient Satisfaction
Time frame: baseline to 6-weeks
Adapted from Camino con Gusto study. 3 questions on satisfaction with the intervention scored on scored on a 4-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree.
Patient Global Impression
Time frame: baseline to 6-weeks
Patient Global Impression of Change (PGIC) captures the patients satisfaction with the intervention by asking "How satisfied or dissatisfied are you with the self-management program?' and is scored on a 7-point scale where 7-point scale where -3 =very dissatisfied 0= neither satisfied or dissatisfied and 3= very satisfied.
6 secondary outcomes
Doctors office visits
Time frame: 6 weeks to 30-34 weeks
Emergency Room use
Time frame: 6 weeks to 30-34 weeks
Self Efficacy
Time frame: 6-weeks to 30-34 weeks
PROMIS Global Health
Time frame: 6-weeks to 30-34 weeks
Pain Catastrophizing
Time frame: 6-weeks to 30-34 weeks
Health Distress
Time frame: 6-weeks to 30-34 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Yes. The study will share de-identified health status pre/post and healthcare utilization information to other investigators upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Gladin, DPT principal investigator
senior physical therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish and Remote feedback active group in people with Chronic Pain, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Efficacy (time frame: baseline to 6-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.