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Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management

24. června 2021 aktualizováno: Wake Forest University Health Sciences

Web-based Pain Self-Management: Nurse-Guided

To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting. Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique. The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible. If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. Wake Baptist may also develop its own web-based CBT for commercial use.

Typ studie

Intervenční

Zápis (Aktuální)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • North Carolina
      • Winston-Salem, North Carolina, Spojené státy, 27104
        • Wake Forest Baptist Health

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria: -

  1. patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
  2. at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
  3. at least 18 years of age;
  4. reliable phone (landline or cell), and
  5. have home computer with reliable internet access.

Exclusion Criteria:

  1. planned elective surgery during the study period;
  2. very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
  3. ongoing unresolved disability claims;
  4. inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
  5. cancer-related musculoskeletal pain;
  6. history of bipolar disorder or schizophrenia; and
  7. takes daily opioid for more than one year.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Telephone Contact (Nurse)
6 regular telephone contacts by nurses who will use a motivational interviewing technique
Behaviorální: Nurse-guided Web-based Cognitive Behavioral Therapy
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
Aktivní komparátor: E-mail contact
6 computer generated email reminders (control arm) over an 8-week period.
Behaviorální: Nurse-guided Web-based Cognitive Behavioral Therapy
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
Časové okno: Up to Week 16
Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
Up to Week 16
PROMIS Pain Interference
Časové okno: Up to Week 16
PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population.
Up to Week 16

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Completed Phone Calls
Časové okno: Up to Week 16
The number of completed phone calls by the nurse will be recorded.
Up to Week 16
Completed Learning Modules Per Treatment Arm
Časové okno: Week 16
The number of completed learning modules per treatment arm will be recorded.
Week 16

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Subjects With Interest in Pain Self-management
Časové okno: Up to Week 16
This refers to the acceptability a subject has to pain self management. This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?"
Up to Week 16
Proportion of Patients Who Viewed Educational Video
Časové okno: Up to Week 16
This refers to the acceptability a subject has to watching the educational video on web-based CBT. This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (EMMI) divided by the number of patients who received the video from EMMI.
Up to Week 16
Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.
Časové okno: Up to Week 16
This refers to the acceptability a subject has to participating in the study. This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video.
Up to Week 16
Ratings of Perceived Disruption
Časové okno: Up to Week 16
This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures
Up to Week 16
Uptake Rates
Časové okno: Up to Week 16
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. For the uptake rate, the number of times participants log in to web-based CBT will be recorded.
Up to Week 16
Self-report Frequency of Practicing Pain Coping Skills
Časové okno: Up to Week 16
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5. Higher scores denote better outcomes.
Up to Week 16
Participant Overall Satisfaction on Web-based CBT Program
Časové okno: Up to Week 16
This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Recorded in a question - scale 0-5. Higher scores denote better outcomes.
Up to Week 16
Nurse's Time
Časové okno: Up to Week 16
This refers to the feasibility of the web-based CBT program. The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded.
Up to Week 16
Perceived Work Rating
Časové okno: Up to Week 16
This refers to the feasibility of the web-based CBT program. Nurses will rate perceived additional work load. Recorded using sing a scale 1-5, higher scores denotes worse outcomes.
Up to Week 16
Motivational Interviewing Treatment Integrity (MITI) Scale
Časové okno: Up to Week 16
This refers to the feasibility of the web-based CBT program. This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI).
Up to Week 16
Mean Opioid Daily Dose
Časové okno: Up to Week 16
This refers to the burden or utilization of health care in relation to the web-based CBT program. The mean daily dose of opioids will be recorded for all participants.
Up to Week 16
Non-study Phone Calls
Časové okno: Up to Week 16
This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of pain relevant phone calls will be recorded.
Up to Week 16
New Referrals to Other Musculoskeletal-related Specialties
Časové okno: Up to Week 16
This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of new referrals to other musculoskeletal-related specialties will be recorded.
Up to Week 16
Number of Emergency Room Visits Related to Pain
Časové okno: Up to Week 16
This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of ER visits per subject related to pain will be recorded.
Up to Week 16
PROMIS Physical Health -Fatigue
Časové okno: Up to Week 16
This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue.
Up to Week 16
PROMIS Physical Health - Physical Function
Časové okno: Up to Week 16
This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment.
Up to Week 16
PROMIS Physical Health - Sleep-related Impairment
Časové okno: Up to Week 16
This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment.
Up to Week 16
PROMIS Physical Health- Pain Behavior
Časové okno: Up to Week 16
This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior.
Up to Week 16
PROMIS Social Health
Časové okno: Up to Week 16
This is a questionnaire that pertains to subject social health. Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions.
Up to Week 16
Brief Pain Inventory (BPI) Pain Severity
Časové okno: Up to Week 16
This is a pain severity questionnaire. BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score.
Up to Week 16
BPI Pain Interference
Časové okno: Up to Week 16
This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items.
Up to Week 16
Pain Catastrophizing Score (PCS)
Časové okno: Up to Week 16
This questionnaire shows the subject's perceived pain. The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome.
Up to Week 16
Global Rating of Change (GRoC)
Časové okno: Up to Week 16
This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed. The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome.
Up to Week 16
Patient Health Questionnaire Depression Scale (PHQ-8)
Časové okno: Up to Week 16
A questionnaire that shows patient's level of depression. Scores can be 0-24, with 0 being the best outcome and 24 being the worst. A score of 10 or greater is considered major depression. A score of 20 or more is severe major depression.
Up to Week 16
Generalized Anxiety Disorder (GAD-7)
Časové okno: Up to Week 16
A questionnaire that shows how much anxiety a subject has. Scores can be 0-18. A score of 5-9 means mild anxiety. A score of 10-14 means moderate anxiety. A score of 15-18 means severe anxiety.
Up to Week 16

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Wake Forest University Health Sciences

Vyšetřovatelé

  • Vrchní vyšetřovatel: Dennis Ang, MD, Wake Forest University Health Sciences

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. července 2019

Primární dokončení (Aktuální)

18. ledna 2021

Dokončení studie (Aktuální)

18. ledna 2021

Termíny zápisu do studia

První předloženo

23. dubna 2019

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2019

První zveřejněno (Aktuální)

25. dubna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

15. července 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. června 2021

Naposledy ověřeno

1. února 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • IRB00056912

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. With assistance from Wake Forest Innovation, Wake Baptist may also develop its own web-based CBT that can be commercialize in the future.

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