Escoge Salud (Choose Health): a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans

NCT04554576 | Completed

• 1 other identifier: 1326143-3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pain

Keywords

Hispanic American; Latino; self-management training; sustainability; health care utilization

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  baseline to 6-weeks

Secondary Outcomes (6)

• Doctors office visits

  6 weeks to 30-34 weeks

• Emergency Room use

  6 weeks to 30-34 weeks

• Self Efficacy

  6-weeks to 30-34 weeks

• PROMIS Global Health

  6-weeks to 30-34 weeks

• Pain Catastrophizing

  6-weeks to 30-34 weeks

Study Arms (2)

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).

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

Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish; Behavioral: Remote feedback control group

Interventions

Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish BEHAVIORAL

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)

Also known as: CDSMP for chronic pain in Spanish

6-week self-management and control group for 6 months; 6-week self-management and remote feedback for 6 months

Remote feedback active group BEHAVIORAL

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)

6-week self-management and remote feedback for 6 months

Remote feedback control group BEHAVIORAL

After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.

6-week self-management and control group for 6 months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spanish Speaking
• Had 1 or 2 outpatient dispense records of NSAIDS between Jan 1 2018 to Dec 31 2018.
• 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

You may not qualify if:

• Major psychiatric or substance abuse problem
• Mild cognitive impairment/dementia
• Malignant pain or terminal illness
• Listed in the Non-contact database

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

KaiserPermanente

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Chronic Pain; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Amy Gladin, DPT

  senior physical therapist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: September 18, 2020
• Study Start: February 14, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: December 2019 to December 2020
• Access Criteria: Available to Investigators upon request

Locations

US (1)