Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05322928 |
| Other study ID # |
SSN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
April 17, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Slagelse Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Previous research has demonstrated that people living with chronic pain who were
physically active could better protect themselves from chronicity. Chronic pain population
has high motivation for initiating lifestyle changes as a part of their multidisciplinary
chronic pain treatment but are often not offered any intervention to improve lifestyle.
Objectives: The project will evaluate feasibility of a telehealth-delivered intervention to
promote compliance with current WHO recommendations on weekly moderate-to-vigorous physical
activity (MVPA) through increased engagement in daily occupations in adults living with
chronic. The feasibility evaluation will inform the design and conduct of a future randomised
controlled trial (RCT).
Method: Forty adults over 18 years old, living a sedentary lifestyle (i.e., self-reported
MVPA<150 min./ week) and completed their standard specialized multidisciplinary chronic pain
rehabilitation at Naestved hospital will be invited to participate in this one-group
pretest-post-test study. A mixed methods methodology will be applied to investigate in
feasibility outcomes (primary) with green-amber-red method, moderate-to-vigorous physical
activity, occupational performance and satisfaction and occupational balance in meaningful
daily activities, pain spreading, pain intensity, central sensitization, pain self-efficacy,
pain catastrophizing, health-related quality of life (HRQoL) and satisfaction with the
treatment.
With inspiration from a previous research project with a three-fold focus on meaningful
activities, physical activity and eating habits that demonstrated the potential of
occupational therapy in lifestyle management in the everyday context, the 12-week
occupational therapy individual person-centered intervention will include 1-hour video
appointments a week in four weeks and a maintenance phase of similar session format every
second week in two months. Individual interviews will add in-depth knowledge on the patients'
opinions on the intervention's mechanism and design.
Description:
Methods Design A mixed methods feasibility study will be applied to investigate whether MVPA
level in adults living with chronic pain can be optimized with an occupational therapy
telehealth intervention. One-group pretest-post-test study will assess feasibility outcomes
with green-amber-red method, MVPA, occupational performance and satisfaction and occupational
balance in meaningful daily activities, pain spreading, pain intensity, central
sensitization, pain self-efficacy, pain catastrophizing, health-related quality of life
(HRQoL) and satisfaction with the treatment. Individual interviews will add in-depth
knowledge on the patients' opinions on the intervention's mechanism and design. The
participants' activity diary notes will support the quantitative and qualitative data
collected.
Participants The project participants will represent adults living with chronic pain and
referred to tertiary chronic pain rehabilitation at a hospital.
Inclusion criteria: Adults over 18 years old, living a sedentary lifestyle (i.e.,
self-reported MVPA <150 min./ week) and diagnosed with fibromyalgia or musculoskeletal pain
in low back, knees, legs, neck, arms and shoulders, who completed their chronic pain
treatment at the Multidisciplinary Pain Centre (MPC) at Naestved hospital will be invited to
participate.
Exclusion criteria: Adults referred to other specialized treatments or health services (e.g.,
delivered by rheumatologists, psychiatrists, physiotherapists or multidisciplinary) after the
tertiary chronic pain rehabilitation, not sufficient Danish writing and speaking proficiency
to allow independent questionnaire completion and translation-free conversation.
Settings Occupational Therapy Unit (OTU) at Naestved hospital in collaboration with the
Multidisciplinary Pain Centre (MPC)
Recruitment The MPC team will invite the patients who are discharged from tertiary chronic
pain rehabilitation to complete a digital PA survey and will transfer contact information on
the patients to the principal investigator (SSN) via Sundhedsplatformen's research list for
the project.
The principal investigator will distribute the PA survey to the patients' ID-based secure
mail. The principal investigator will invite those who reported MVPA <150 min./ week to
participate in an online information meeting about the project (Region Zealand
VDX-connection). After considering their participation for one week, the patients who provide
informed consent on participation will be included.
Two of the participants will be invited to function as reference persons, to ensure adequate
user involvement in the intervention feasibility evaluation and preparation of the RCT. All
the participants will be invited to participate in the qualitative interviews after the
intervention discharge (Region Zealand VDX connection). A representative sample regarding
age, sex and geographical area within Region Zealand will be included for the interviews.
Intervention The 12-week occupational therapy individual person-centered intervention will
start from the participants' baseline appointment at the OTU. The experimental contents will
be delivered by an occupational therapist according to the individual intervention plan, with
a 1-hour video appointment (Region Zealand VDX-connection) a week in four weeks and a
maintenance phase of similar session format every second week in two months. After three
months in total, the participants will meet for a follow-up assessment and discharge from the
intervention.
The intervention is inspired by a previous research project with a three-fold focus on
meaningful activities, physical activity and eating habits that demonstrated the potential of
occupational therapy in lifestyle management in the everyday context. The intervention will
include identification of occupational problems that limit compliance with the PA
recommendations, setting tailored occupational goals to enhance physically active lifestyle,
supervised goal work and goal evaluation. Through active involvement in value-based
prioritizing, planning and performance of meaningful everyday activities, the participants
will reduce their sedentary time. Changing health behaviour in a stepwise manner, the
participants will become prepared for continuous lifestyle goal work as self-management which
will allow for sustainable lifestyle changes, and thus, improved health and quality of life
in the long term.
Providers At the start of the project, the intervention will be delivered by the principal
investigator who is a graduated occupational therapist with 13 years of experience. Later,
additional intervention providers (graduated occupational therapists from the OUT) will be
involved.
Assessment The pre-post intervention assessments will take place at the OTU at Naestved
Hospital in a quiet room reserved for the purpose. Assessment sessions will not require any
specific prerequisites in the participants. Caretakers will be allowed to participate in the
assessment sessions. For assessments in paper form, separate files will be used at the
baseline and follow-up, to prevent the assessor bias.
Outcomes The choice of the intervention outcomes is guided by the study objectives, The
Medical Research Council framework for developing and evaluating complex interventions and
the IMMPACT recommendations and include outcomes related to the intervention feasibility,
physical health (MVPA time and walking steps), everyday activity (occupational performance
and satisfaction, and occupational balance), pain (central sensitization, pain spreading,
pain intensity and pain self-efficacy), psychological state (pain catastrophizing), sleep
(sleep quality), general well-being (HRQoL) and treatment satisfaction.
Quantitative & quantifiable outcomes A. Feasibility outcomes will be primary outcomes for the
project. Feasibility: Feasibility of the procedures planned will be assessed using predefined
research progression criteria evaluated by the green-amber-red method. The green-amber-red
method where GREEN: Proceed with RCT/implementation; AMBER: Proceed, but changes to the
protocol need to be discussed and solved; and RED: Do not proceed unless the problem can be
solved, will help evaluate the readiness of the intervention to be tested for effectiveness
in an RCT. The predefined research progression criteria will be set for the recruitment;
participant retention; program adherence; patients' self-perceived relevance; timing and mode
of delivery; assessment procedure acceptance; adverse events; fidelity of delivery; and
contextual appropriateness. Detailed description of adverse events is provided below, in a
separate section.
B. Secondary outcomes will be assessed before and after intervention.
Qualitative outcomes Individual opinions on the intervention and its self-perceived outcomes
will be collected post-intervention. Important themes will be extracted from the transcribed
interview data.
Sample size No formal sample size will be calculated. A convenient sample of 30 patients will
be included in the project in total, preferably representing different age and sex groups and
geographical areas within the Region Zealand. All the participants will be invited to
participate in the individual interviews post-discharge. A minimum of 6 patients will be
attempted included in the interviews, to ensure data saturation.
Analysis Quantitative analyses: According to the normality check results, the data will be
described by mean ± SD or median(range) and analyzed for pre-post changes. Parametric or
nonparametric statistics will be applied to the data analysis performed using the STATA 17.0
software (StataCorp, Texas, USA).
Qualitative analysis: The interview data will be transcribed verbatim and analyzed with the
thematic analysis methodology.
Results Primary outcomes will inform further research steps and the intervention potential
for implementation. Secondary outcomes are expected to improve during the intervention but
vary in degree among the participants.
Ethics Digital data will be stored in the project's SharePoint (registration of
participation), Redcap database (survey data) and encrypted USB (interview data). Data in
paper form will be stored at the OTU at a double-locked location. Access to the project data
will be sought granted by a formal agreement from the Data Protection Committee for any
person involved in data collection and management.
The project will be approved by the Data Protection Committee of Region Zealand and follow
the World Medical Association (WMA) Declaration of Helsinki. Dispensation from formal ethical
approval was sought at The Ethic Committee in Region Zealand and is awaiting a decision.
Adverse events Serious adverse events registration will be included in the participant
diaries and the generic follow-up questionnaire. Any undesirable experience associated with
the use of healthcare services or medication in a patient that may lead to discontinuation
from the project or a longer term disruption in the personal intervention participation plan
will be considered an adverse event, e.g., death, hospitalization, injury, impairment,
serious illness requiring medication (somatic or psychiatric) or an increase in pain
medication.
The project has no expected risks of adverse effects. In case of injury, all the participants
have their right to seek patient compensation according to the current legislation rules.
Dissemination plan The project will be reported according to the Standards for QUality
Improvement Reporting Excellence (SQUIRE) framework for reporting new knowledge about how to
improve healthcare and the CONSORT extension for pilot and feasibility trials. All the
results - positive, negative or undecisive - will be published in peer-reviewed scientific
journals. The participants will receive a brief report with the results of their
participation as standard.
Funding The project is funded by the Exercise First program grant from Region Zealand.
External funding will be sought.
