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

24. Juni 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Winston-Salem, North Carolina, Vereinigte Staaten, 27104
        • Wake Forest Baptist Health

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Completed Phone Calls
Zeitfenster: 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
Zeitfenster: Week 16
The number of completed learning modules per treatment arm will be recorded.
Week 16

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Subjects With Interest in Pain Self-management
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Ermittler

  • Hauptermittler: Dennis Ang, MD, Wake Forest University Health Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Juli 2019

Primärer Abschluss (Tatsächlich)

18. Januar 2021

Studienabschluss (Tatsächlich)

18. Januar 2021

Studienanmeldedaten

Zuerst eingereicht

23. April 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2019

Zuerst gepostet (Tatsächlich)

25. April 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2021

Zuletzt verifiziert

1. Februar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00056912

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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