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Supporting Self-management of Chronic Pain

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ClinicalTrials.gov Identifier: NCT03119896
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
The Thistle Foundation
Health and Social Care Alliance Scotland (the ALLIANCE)
Edinburgh and Lothians Health Foundation
Information provided by (Responsible Party):
Pain Concern

Brief Summary:

Does the Navigator Tool Intervention improve communication regarding self-management during consultations between healthcare professionals and people with chronic pain?

As there is usually no cure for chronic pain, healthcare professionals are increasingly turning to methods of treatment that emphasise management of symptoms rather than elimination of pain. However, as Pain Concern's previous research has shown, there are several barriers to self-management that both healthcare professionals and people with pain face in their consultations in primary care. The Navigator Tool Intervention has been designed to overcome the majority of these barriers through improving the quality of communication regarding self-management during consultations.

In line with the House of Care Model, where care relies on engaged and informed patients, healthcare professionals committed to partnership working, and organisational processes that support this, our intervention prepares both the healthcare professionals and patients for their consultation. By providing a training session for the healthcare professionals in how supported self-management can be brought into the consultation room, and by providing the patients with a paper-based tool that allows them to organise their concerns and questions prior to the consultation, the intervention aims to steer the conversation toward the aspects that the patient needs to discuss in order to better manage their pain.

This study will launch the intervention and evaluate its effectiveness in improving self-management support through conversation. It will be launched over a 3 month period in 4 sites across Scotland; 24 patients will be using the tool with a trained healthcare professional and 24 will act as a control group, receiving standard care without the tool.

Questionnaires assessing the satisfaction with the consultation(s) and communication, as well as confidence in managing one's pain, will be analysed and compared between the two groups. Interviews will be carried out with healthcare professionals and a sample of patients having used the tool to gain a deeper understanding of the usefulness of the intervention and how it may be improved in the future.


Condition or disease Intervention/treatment Phase
Chronic Pain Syndrome Chronic Pain Chronic Pain Due to Injury Chronic Pain Due to Trauma Chronic Pain Due to Malignancy (Finding) Chronic Pain Post-Procedural Chronic Pain Hip Chronic Pain, Widespread Other: The Navigator Tool Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups; one "active group" receiving the intervention, and one "control group" receiving standard care without the intervention.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Supporting Self-management in Chronic Pain: a Collaborative Approach Providing Relevant Tools to Healthcare Professionals and People With Pain.
Actual Study Start Date : August 28, 2017
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Intervention Group (using Navigator Tool)
The participants will receive a copy of the Navigator Tool Intervention, a paper-based information pack including the My Pain Concerns Form, suggested questions to ask your healthcare professional, a goal setting sheet and information on common self-management strategies. They will be encouraged to fill in some of the forms before the consultation, and some during the consultation. They will have consultations with a healthcare professional who has undergone a Self-management Awareness Training with the Thistle Foundation.
Other: The Navigator Tool Intervention
The intervention consists of two parts; a training session on self-management of chronic conditions for the healthcare professionals, and a paper-based tool for the patients. Both parts aim to inform and prepare the two parties as to what self-management entails in order to facilitate a constrictive consultation.

No Intervention: Control Group (not using Navigator Tool)
These participants will not have access to the Navigator Tool Intervention, and will have consultations with a healthcare professional who has not undergone the Self-management Awareness Training.



Primary Outcome Measures :
  1. Transcripts of semi-structured interviews with healthcare professionals and patients from Intervention group [ Time Frame: Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place). ]
    Transcripts will be analysed and coded for themes and attitudes, similar concerns and experiences regarding the experience of using the intervention.


Secondary Outcome Measures :
  1. Consultation Quality Index - 2 (CQI-2) [ Time Frame: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it. ]
    Assesses improvement and satisfaction with the communication during consultations. (Patients only)

  2. Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: First one distributed 1 week before the intervention starts, to be completed and submitted within 1 week. Second will be distributed 1 week after the intervention has ended, to be returned within 1-2 weeks after having received it. ]
    Assesses improvement to the patients ability to confidently manage their own pain.

  3. CARE measure [ Time Frame: Distributed to participants 1 week after the intervention has finished, they will return the filled in questionnaire within 1-2 weeks of having received it. ]
    Assesses satisfaction with the communication during consultations. (Patients only)


Other Outcome Measures:
  1. Transcripts of semi structured interviews with healthcare professionals and patients from the intervention group. [ Time Frame: Interviews will be carried out 1-2 months after the intervention has finished (the last consultation has taken place). ]
    Transcripts will be analysed and coded to elicit attitudes toward strengths and weaknesses of the intervention. It will identify possible improvements and changes to make the intervention easier to use and/or more effective.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be over 18 years of age
  • Have experienced pain for more than 3 months

Exclusion Criteria:

  • Being unable to communicate in English
  • Being unable to attend consultations with a healthcare professional for the duration of the project
  • Being currently participating in another research project regarding chronic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119896


Locations
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United Kingdom
St Margaret's Health Centre
Auchterarder, Scotland, United Kingdom, PH3 1JH
Whitesands Medical Practice
Dunbar, Scotland, United Kingdom, EH42 1EE
St Triduana's Medical Practice
Edinburgh, Scotland, United Kingdom, 6RU
Milngavie Clinic
Milngavie, Scotland, United Kingdom, G62 7AA
Muirhead Medical Centre
Muirhead, Scotland, United Kingdom, DD2 5NH
Sponsors and Collaborators
Pain Concern
The Thistle Foundation
Health and Social Care Alliance Scotland (the ALLIANCE)
Edinburgh and Lothians Health Foundation
Investigators
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Principal Investigator: Pamela F Bell, MB FFARCSI FFPMCAI FFPMRCA Pain Concern

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Responsible Party: Pain Concern
ClinicalTrials.gov Identifier: NCT03119896     History of Changes
Other Study ID Numbers: 223092
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Pain Concern:
chronic pain
self-management
pain management
doctor patient communication
primary care

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms