Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04283786 |
| Other study ID # |
43961 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 6, 2020 |
| Est. completion date |
May 31, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Nottingham University Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Osteoporosis is a condition where bones become weak and fragile and can easily break.
Suffering from one fragility fracture doubles your chance of having another. These fractures
can affect a person's life significantly and contribute to significant costs to the UK
(United Kingdom) health service.
Bisphosphonates are used to treat osteoporosis and help prevent fractures. The most commonly
used bisphosphonate treatment is Alendronate, but taking it correctly is complicated and
side-effects are common. Therefore only 1 in 4 people continue with Alendronate beyond 2
years. There are different forms of bisphosphonates that can be given in different ways and
frequencies and may be more acceptable and tolerated by patients.
The study will look at how effective different bisphosphonate regimens are compared to
Alendronate at preventing fractures, whether the reduction in fracture risk can be achieved
at reasonable financial cost and establish acceptability of different approaches to patients.
The study will be completed in 2 stages, Stage 1A and Stage 1B in parallel, followed by Stage
2.
Stage 1A will update a systematic review to inform which regimens are most effective at
reducing fractures and provide the best value for money.
Stage 1B will consist of qualitative, semi-structured interviews from a sample of
stakeholders in receipt of or involved in the delivery of different bisphosphonate regimens,
in order to identify which bisphosphonate regimens are most acceptable to patients and the
barriers to effective compliance and adherence.
Stage 2 will use focus groups and workshops with stakeholders and commissioners to discuss
uncertainties from Stage 1 and identify the most important outstanding questions for future
research.
Description:
This information provided relates to Stage 1B. Stage 1A does not involve participants. Stage
2 will be conducted by the Royal Osteoporosis Society. Participants will not be invited via
NHS (National Health Service) organisations and no identifiable information will be
collected.
Participants are only involved in Stage 1B of the study, which consists of qualitative
interviews only. Participants will be drawn from several different areas of healthcare, in
order to ensure a best range of relevant patients', clinicians', commissioners', service
managers' and researchers' experiences. Patient participants will be identified as
potentially eligible by their healthcare providers, either via their GP (General
Practitioner) surgery or secondary care clinician.
Patients will receive a Study Information Pack via the post, containing an Invitation
(Patient) Letter from their GP or responsible secondary care doctor, a Participant (Patient)
Information Sheet, a reply slip and a freepost envelope with the Research Team's return
address. This information pack will also include the Research Team's contact details in order
that potential participants have an opportunity to ask questions before indicating an
interest in taking part in the study. Patients may also contact the Research Team to express
interest by response to a Patient Information Poster in certain service areas, and they will
be supplied with the same Study Information Pack. Patients who return a reply slip will be
contacted by a member of the Research Team to arrange a convenient time and location in which
to obtain written informed consent and undertake the semi-structured interview, which is
likely to be immediately after written consent is obtained.
Non-patient participants will be identified as potentially eligible via their General
Practice Managers or via snowball sampling from their Service Lead in secondary care
services. They will be provided with an Invitation (Clinician) Letter/Email and Participant
(Clinician) Information Sheet. The information pack will also include the Research Team's
contact details in order that potential participants have an opportunity to ask questions
before indicating an interest in taking part in the study. If they indicate to the Research
Team they would like to participate in the study, a member of the Research Team will contact
the participant to obtain written informed consent, before arranging a convenient time and
location to undertake the semi-structured interview, which may be immediately after written
consent is obtained.
The semi-structured interviews will be conducted face-to-face or by telephone and are
expected to take 40-50 minutes to complete. Face-to-face interviews will be conducted in a
private setting either within the site of treatment or at their home in the case of a patient
participant, or within the place of work for non-patient participants.
The interview guide will be developed iteratively throughout the study to cover issues as
identified from the scoping review of published studies assessing experiences of
bisphosphonate regimens, as well as wider experiences of service quality and delivery. This
will include questions around patient factors (such as values and health beliefs), service
factors (location, accessibility, assurance, and empathy), relational factors (provider
patient relations) and medication factors (dosing complexity, frequency, side effects).
Clinician interviews will also include barriers to maintain a service around alternative
bisphosphonates regimens, as well as changes in service over time.
Interviews will be undertaken by qualitative researchers (employed by University of
Nottingham). Interviews will be audio-recorded and then transcribed by Clayton Research
Support, a Nottingham University Hospitals and University of Nottingham approved
transcription service.
There is no intervention involved in this study. Once the interview is completed, a
participant's involvement in the study is ended. There is no further follow-up.
Thematic analysis of interview data will be conducted. This will involve familiarisation,
identification of a framework, and interpretation, paying particular attention to themes
clustered around service variables. The analysis will involve a preliminary phase of more
general qualitative data analysis (close reading of transcripts, open coding, identification
of themes). Analysis will be undertaken in the first instance by the Research Fellow
alongside and overseen by the Stage 1B Lead. Emerging themes (with all identifying
information removed) will be discussed at appropriate intervals with the wider study
management group. The approach will allow for both a-priori and emergent codes to be
identified. NVivo software will be used to develop an appropriate coding strategy and
framework.
Due to the Covid-19 pandemic and the need for a contingency recruitment plan, Non-substantial
Amendment 02 was submitted and approved on 15th May 2020 to facilitate patient recruitment
from the Royal Osteoporosis Society members via newsletter article, allowing interviews to be
conducted by telephone rather than face-to-face at a specific location.
