Northumbria osteoporosis project: Group clinics
| ISRCTN | ISRCTN56916730 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56916730 |
| Secondary identifying numbers | 12765 |
- Submission date
- 19/06/2017
- Registration date
- 01/09/2017
- Last edited
- 26/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis (weak or brittle bones) is common and often missed. Group clinics can be an option to try and diagnose this condition. Group clinics are effective and efficient in patients with arthritis (a type of swelling in the joints); however it is unsure if group clinics work for osteoporosis. The aim of this study is to see if a group clinic led by a pharmacist were as effective as usual care for people with osteoporosis.
Who can participate?
Adults over 50 with high fracture risk.
What does the study involve?
Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use.
What are the possible benefits and risks of participating?
There are no benefits with participating. There are no direct risks, however participants may not like being seen in a group setting.
Where is the study run from?
This study is being run by Northumbria Healthcare (UK) and takes place practices in Northumberland CCG (UK).
When is the study starting and how long is it expected to run for?
August 2010 to August 2018
Who is funding the study?
1. National Osteoporosis Society (UK)
2. National Institute for Health Research (UK)
Who is the main contact?
1. Dr Fraser Birrell (Scientific)
Fraser.birrell@newcastle.ac.uk
2. Mrs Norma Cardill (Public)
norma.cardill@northumbria-healthcare.nhs.uk
Contact information
Public
Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
| Phone | +44 1670 529903 |
|---|---|
| norma.cardill@northumbria-healthcare.nhs.uk |
Scientific
Northumbria Healthcare NHS Foundation Trust
Rake Lane
North Shields
NE29 8NH
United Kingdom
| Phone | +44 1670 529903 |
|---|---|
| Fraser.Birrell@ncl.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Not Specified, Not Specified, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Northumbria Osteoporosis Project: A randomised controlled trial of managing patients needing bone protection treatment through group clinics vs usual one to one care |
| Study objectives | There will be no significant difference between medicines adherence as measured by Mean Possession Ratio (MPR) when compared with usual care (1:1 clinic), in patients being prescribed bisphosphonates for fracture prevention. |
| Ethics approval(s) | NRES Committee North East - Newcastle & North Tyneside 1, 21/12/2010, 10/H0906/88 |
| Health condition(s) or problem(s) studied | Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic Bone Disease |
| Intervention | Participants with high risk of fracture were identified by their practice. They were sent a letter to invite them to take part in the study. Those accepting were randomised to group clinic or usual care and seen once. In either setting they had education about osteoporosis and prescribed standard treatment. Participants are randomly allocated using a random number table to either the intervention or the control group. Those in the intervention group attend a single Pharmacist-led group clinic. Those in the control group receive the usual care, which is a single consultation delivered by Pharmacist. Participants are followed up for 12 months for medication use. |
| Intervention type | Behavioural |
| Primary outcome measure | Mean possession ratio (MPR) of bisphosphonates is measured using practice prescription records at 12 months |
| Secondary outcome measures | 1. Persistence with treatment is the time (in months) before the drug is no longer requested measured using practice prescription records by month up to 12 months 2. Patient satisfaction with group clinics, enabling factors and active ingredients were explored with qualitative interviews of osteoporosis group clinic participants and comparison with an established, but co-designed and therefore evolving inflammatory arthritis group clinic model 3. Cost analysis of the intervention was restricted to staff costs of, as assumptions of other costs being equivalent were met |
| Overall study start date | 24/08/2010 |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 214; UK Sample Size: 214 |
| Key inclusion criteria | 1. Patients identified as high risk of an osteoporotic fracture, needing treatment 2. Patients aged 50 years and over 3. Patients giving informed consent to the study |
| Key exclusion criteria | 1. Patients not eligible for first line treatment as defined by North of Tyne Osteoporosis Guidance (encompassing FRAX calculation and NOGG guideline) 2. Patients not wishing to participate in the study 3. Patients unable to consent to participate in the study 4. Patient contraindications to bisphosphonates (upper gastrointestinal problems, severe impairment GFR<35ml/min, previous intolerance) 5. Terminally ill patients 6. Housebound patients |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 31/07/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NE29 8NH
United Kingdom
NE22 6JX
United Kingdom
NE63 0XX
United Kingdom
Ashington
NE63 9UT
United Kingdom
Sponsor information
Hospital/treatment centre
Northumbria Healthcare NHS Foundation Trust
Research & Development
Rake Lane
North Shields
NE29 8NH
England
United Kingdom
"ROR" |
https://ror.org/01zy11s57 |
|---|
Funders
Funder type
Government
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- NOS
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from wasim.baqir@nhs.net |
Editorial Notes
26/10/2017: Internal review.
