Quality of Life and the Effects of Tailored Health Coaching in Fibromyalgia Patients

Summary

Specific Aims:

1. To identify phenotypes of patients with fibromyalgia according to symptom clusters and to compare differences in quality of life (QOL) among different phenotypes.
2. To examine the effects of technology-assisted and tailored health coaching in comparison to telephone support on health status, QOL, pain catastrophizing, and self-efficacy in patients with fibromyalgia.

Methods:

For Aims 1, the investigators will conduct a cross-sectional study and enroll 300 patients with fibromyalgia. Symptoms will be assessed using the Numerical Rating Scale, Athens Insomnia Scale, Functional Assessment of Cancer Therapy cognition scale, Beck Depression Index-II, Beck Anxiety Index, and Fatigue Severity Scale. The World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) questionnaire will be used to assess participants' overall QOL. Hierarchical cluster analyses will be used to identify fibromyalgia phenotypes according to pain, physical, and psychological variables. A series of multivariate analysis of variance analyses will be used to compare the differences in WHOQOL-BREF scores among those phenotypes.

For Aims 2, the investigators conduct an assessor-blind, parallel-group, randomized controlled trial and enroll 110 participants with fibromyalgia. Participants will be randomized to a health coaching group and a control group. The tailored, interactive health-coaching program will be delivered via mobile applications during a 10-week training period. The control group will receive standard education materials and weekly telephone support. The primary outcomes are the revised Fibromyalgia Impact Questionnaire and WHOQOL-BREF scores; the secondary outcomes are pain catastrophizing score and self-efficacy, which will be examined at baseline, post-training, and the 3th month follow-up. Data will be analyzed according to the intention-to-treat principle. To determine the effectiveness of health coaching on primary and secondary outcomes, differences in outcome variables will be analyzed with mixed-effects linear regression models. The between-group differences at the two posttests examined using a mixed-model will include group x time interaction. The investigators will adjust for the baseline score on the outcome variable and for demographics and comorbidities that differ significantly between the intervention and control groups at baseline.

Conditions

• Fibromyalgia

Interventions

BEHAVIORAL

health coach

The health-coaching program includes (1) my file, (2) lesson, (3) self-assessment, and (4) interaction modules. My file allows participants recording their disease history. The lesson includes knowledge of fibromyalgia, stress and relaxation, emotion and positive thinking, sleep hygiene, communication skills, and exercise. The self-assessments includes symptom diary, exercise and general diary. The interaction encourages participants interacting with peers and the health coach. Participants can share practical advices, strategies, real-life examples or questions via texts or photos in "share garden". Participants can connect to the health coach via "contact with health coach". The coach will provide comments or responses approximately 10-30 min for each time. The coach will monitor each participant's lesson list and attendance for each lesson. The health coach will also guide the participants to create their own tailored programs according to participants' predominant symptom subtypes.

Sponsors & Collaborators

• Ministry of Science and Technology, Taiwan

  collaborator OTHER_GOV

• Taipei Medical University

  lead OTHER

Principal Investigators

• Pei-Shan Tsai, PhD · Taipei Medical University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-15

Primary Completion

2021-11-19

Completion

2022-11-06

Countries

• Taiwan

Study Locations