Dataset Information

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

ABSTRACT:

Background

This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.

Methods

A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC), and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.

Results

The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively) than in the WL Group (8%, 12%, 20%). The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%). The proportion of patients who reported ? 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12%) and 3 months post-intervention (33% vs 4%). Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.

Conclusion

The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.

Trial registration

International Standard Randomized Controlled Trial Number Register ISRCTN14526380.

SUBMITTER: Bourgault P

PROVIDER: S-EPMC4433106 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Publications

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

Bourgault Patricia P Lacasse Anaïs A Marchand Serge S Courtemanche-Harel Roxanne R Charest Jacques J Gaumond Isabelle I Barcellos de Souza Juliana J Choinière Manon M

PloS one 20150515 5

<h4>Background</h4>This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.<h4>Methods</h4>A mixed-methods randomized controlled trial (intervention (INT) vs. waitlist (WL)) was conducted with patients suffering from FMS. Data were collected at baseline (T0), at the end of the intervention (T1), and 3 months later (T2). The primary outcome was change in pain intensity (0-10). Secondary outcomes were ...[more]

PMID: 25978402

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Project description:ObjectiveTo obtain insight into experiences of patients with a neuromuscular disease and chronic fatigue and their healthcare professionals regarding content and delivery of a multidisciplinary outpatient self-management group programme to improve social participation. This will inform future implementation.DesignA mixed method study alongside a randomised controlled trial.SettingUniversity hospital, rehabilitation centre and community health centre.Participants29 patients with a neuromuscular disease and chronic fatigue and 13 healthcare professionals participated in this mixed methods study.InterventionMultidisciplinary group programme, called Energetic, consisted of a 4 months intervention with weekly meetings and covered four modules: (1) individually tailored aerobic exercise training; (2) education about aerobic exercise; (3) self-management training in applying energy conservation strategies and (4) implementation and relapse prevention in daily life.Main measuresQuantitative data were collected by a questionnaire measuring patients' (n=25, all completed the programme) satisfaction with the perceived results, content and delivery of the programme. Qualitative data were collected by individual and focus group interviews to gain insight in the experiences of patients (n=18), next of kin (n=2) and healthcare professionals (n=13) with facilitators and barriers to programme implementation.ResultsPatients were satisfied with the number and length of the sessions, the different modules and the therapists. Analysis of the interviews led to five themes: (1) the combination of modules makes a complete picture, (2) the programme is physically and mentally intensive, (3) the group setting is valuable, (4) small variations in delivery occur in different settings, (5) therapists are coaches. Suggestions for programme improvement include a combination of face to face and e-health, enhancement of therapists' skills in guiding group interventions and inclusion of more booster sessions to evaluate and maintain self-management competencies.ConclusionsThe Energetic programme could be implemented in different healthcare settings and group settings, and a combination of modules proved to be a facilitator for improving self-management.Trial registration numberNCT02208687.

Project description:BACKGROUND:Self-management strategies are effective in a number of medical conditions; however, implementation studies have demonstrated adoption into clinical practice can be problematic. The process of implementation was explored during a pilot randomised controlled trial evaluating postpartum blood pressure self-management in women with medicated hypertensive disorders of pregnancy. METHODS:A mixed methods study using semi-structured interviews with a qualitative and a scored (quantitative) component were undertaken as part of a pilot randomised controlled trial (SNAP-HT) in postnatal women with medicated gestational hypertension or pre-eclampsia. Women were randomised to usual care or blood pressure self-management. Self-management entailed daily home blood pressure monitoring and automated medication reduction via telemonitoring. Women from both groups optionally consented to participate in audio-recorded interviews at 4 weeks and 6 months postpartum. Interview questions were developed to explore the proposed benefits of self-management and the constructs of normalisation process theory. Participants provided a score (Likert scale 1-5) for each question and were encouraged to expand upon these answers through further discussion. The interviews were transcribed and analysed using the framework approach. RESULTS:Sixty-eight women, 34 from each randomised group, completed at least one audio-recorded interview. Several overarching themes emerged from analysis of 126 interview transcripts: control; convenience; confidence, communication and knowledge; concern; constraints; and components of the intervention. In the scored component of the analysis, both groups reported feeling more in control of their condition postpartum compared to during pregnancy, more so in those self-managing at both 4 weeks and 6 months: adjusted differences 0.6 (95% confidence interval [CI] 0.2 to 1.1) and 0.7 (95% CI 0.3 to 1.2) respectively. CONCLUSIONS:Interviews and quantitative data showed that self-management enhanced women's sense of control and improved their blood pressure-related anxiety. Prior to taking part, a few women anticipated that home monitoring might increase anxiety, but stated that it had the opposite effect. Self-management was perceived as more flexible and reactive and as enabling more targeted down-titration of medication. These data provide considerable support for blood pressure self-management postpartum and reinforce the effectiveness of the intervention used in this study. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02333240. Prospectively registered on 7 January 2015.

Project description:BACKGROUND:Optimal self-management in kidney transplant recipients is essential for patient and graft survival, reducing comorbidity and health care costs while improving the quality of life. However, there are few effective interventions aimed at providing self-management support after kidney transplantation. OBJECTIVE:This study aims to systematically develop a nurse-led, self-management (support) intervention for kidney transplant recipients. METHODS:The Intervention Mapping protocol was used to develop an intervention that incorporates kidney transplant recipients' and nurses' needs, and theories as well as evidence-based methods. The needs of recipients and nurses were assessed by reviewing the literature, conducting focus groups, individual interviews, and observations (step 1). Based on the needs assessment, Self-Regulation Theory, and the "5A's" model, change objectives were formulated (step 2). Evidence-based methods to achieve these objectives were selected and subsequently translated into practical implementation strategies (step 3). Then, program materials and protocols were developed accordingly (step 4). The implementation to test the feasibility and acceptability was scheduled for 2015-2017 (step 5). The last step of Intervention Mapping, evaluation of the intervention, falls outside the scope of this paper (step 6). RESULTS:The intervention was developed to optimize self-management (support) after kidney transplantation and targeted both kidney transplant recipients and nurse practitioners who delivered the intervention. The intervention was clustered into four 15-minute sessions that were combined with regular appointments at the outpatient clinic. Nurses received a training syllabus and were trained in communication techniques based on the principles of Solution-Focused Brief Therapy and Motivational Interviewing; this entailed guiding the patients to generate their own goals and solutions and focus on strengths and successes. Kidney transplant recipients were encouraged to assess self-management challenges using the Self-Management Web and subsequently develop specific goals, action plans, and pursuit skills to solve these challenges. CONCLUSIONS:The Intervention Mapping protocol provided a rigorous framework to systematically develop a self-management intervention in which nurses and kidney transplant recipients' needs, evidence-based methods, and theories were integrated. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11856.

Project description:BackgroundDespite continuous improvements in anti-rheumatic pharmacological treatment, people with chronic inflammatory arthritis still report substantial disease impact. Based on the framework for complex interventions, we thus developed INSELMA, a novel nurse-coordinated multidisciplinary self-management intervention for patients with rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis. Based on individual biopsychosocial assessments, a rheumatology nurse facilitated goal setting and coordinated interdisciplinary support. The aim of this study was to explore the patients' experience of participating in the six-months INSELMA intervention.MethodsIndividual semi-structured interviews were conducted with 15 of the participants after their final follow-up. Thematic analysis was applied.ResultsThe analysis derived four overall themes. (1) A new opportunity at the right time. The participants' disease impacted all areas of daily life. Participation in INSELMA was experienced as an opportunity to improve symptoms and together reduce long-held challenges they had fought alone, until now. (2) The importance of person-centred goals. The participants found it meaningful to work with their individual goals, which encompassed physical, psychological, and social factors. Having time between consultations to work with goals at home was important. (3) Empathy, partnership and a little nudging from health professionals are essential. The empathic nurses' continuous support and coaching helped participants become aware of their own resources. The participants highlighted having access to support from a physiotherapist and occupational therapist with rheumatology experience as important. (4) I got more than I could have hoped for. Most of the participants experienced decreased symptom load and improvement in physical strength, mobility, sleep, and mood as well as increased energy, knowledge, and self-management ability. The participants expressed new hope for the future with an improved ability to manage their symptoms and work towards new goals.ConclusionThe participants found the INSELMA intervention meaningful and feasible. They experienced decreased disease impact and increased activity levels, facilitated by empathy and self-management support from health professionals.

Project description:BackgroundThere is limited research of electronic tools for self-management for patients with chronic kidney disease (CKD). We sought to evaluate participant engagement, perceived self-efficacy and website usage in a preliminary evaluation of My Kidneys My Health, a patient-facing eHealth tool in Canada.MethodsWe conducted an explanatory sequential mixed-methods study of adults with CKD who were not on kidney replacement therapy and who had access to My Kidneys My Health for 8 weeks. Outcomes included acceptance (measured by the Technology Acceptance Model), self-efficacy (measured by the Chronic Disease Self-Efficacy Scale [CDSES]) and website usage patterns (captured using Google Analytics). We analyzed participant interviews using qualitative content analysis.ResultsTwenty-nine participants with CKD completed baseline questionnaires, of whom 22 completed end-of-study questionnaires; data saturation was achieved with 15 telephone interviews. Acceptance was high, with more than 70% of participants agreeing or strongly agreeing that the website was easy to use and useful. Of the 22 who completed end-of-study questionnaires, 18 (82%) indicated they would recommend its use to others and 16 (73%) stated they would use the website in the future. Average scores for website satisfaction and look and feel were 7.7 (standard deviation [SD] 2.0) and 8.2 (SD 2.0) out of 10, respectively. The CDSES indicated that participants gained an increase in CKD information. Interviewed participants reported that the website offered valuable information and interactive tools for patients with early or newly diagnosed CKD, or for those experiencing changes in health status. Popular website pages and interactive features included Food and Diet, What is CKD, My Question List and the Depression Screener.InterpretationParticipants indicated that the My Kidneys My Health website provided accessible content and tools that may improve self-efficacy and support in CKD self-management. Further evaluation of the website's effectiveness in supporting self-management among a larger, more heterogenous population is warranted.

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Dataset Information

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

Background

Methods

Results

Conclusion

Trial registration

Publications

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

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