Overcoming psychological stress to injections for type 2 diabetes
| ISRCTN | ISRCTN16710901 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16710901 |
| Secondary identifying numbers | WT 13/48 156708 |
- Submission date
- 05/08/2015
- Registration date
- 21/08/2015
- Last edited
- 10/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many people suffering from type 2 diabetes mellitus (T2DM) will eventually need injection treatment to control their blood sugar levels. There is strong evidence to suggest that good control of blood sugar levels helps to lower the risk of complications from T2DM long term. For many patients, being told that they will have to start injection treatment can cause anxiety (psychological stress). This can lead to delays or even refusal of treatment, which is potentially harmful to their health. It has been suggested that educating patients on injection therapy and addressing patient concerns could help to prevent psychological stress. The aim of this study is to investigate whether attending an educational programme before starting the injection treatment can help to lower levels of anxiety in patients.
Who can participate?
Adults with T2DM at risk of hyperglycaemia (high blood sugar) who are suitable for injectable therapy
What does the study involve?
The study is made up of two phases. In phase one, four focus groups are created to help identify common concerns people have about injection therapy and how best to address these problems in an educational programme. Three of the focus groups are made up of people who have started injection therapy within the last year, and the other is made up of people who have refused injection therapy within the last year. From the information collected from these focus groups, an educational programme is designed for use in phase two of the study. In phase two of the study, participants are randomly divided into two groups. The first (control) group meets with a diabetes specialist nurse who will start the therapy and provide information about general healthy eating. The section group will be invited to go to the next education programme near them, before meeting with a diabetes specialist nurse who will start the therapy. All participants will complete questionnaires designed to measure their emotional wellbeing, diet and knowledge about diabetes and the injection treatment. These measurements will be taken at the start of the study, after 12 weeks and 24 weeks.
What are the possible benefits and risks of participating?
Those that take part will help shape and improve services for future patients with type 2 diabetes starting injection treatment and may also improve their own knowledge and how they manage their diabetes going forward. The study is unlikely to put those that take part at risk; however some may find certain question items to be personal as we are exploring stress and anxiety levels. To reduce any risk, a 'distress protocol' has been created.
Where is the study run from?
Altnagelvin Area Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2014 to September 2017
Who is funding the study?
The Health and Social Care Research and Development Division of the Public Health Agency (UK)
Who is the main contact?
Miss Deirdre McCay
Contact information
Scientific
Dietetic Department
Level 10
Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
Public
Dietetic Department
Level 10
Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom
Study information
| Study design | Single-centre 2 phase study. Phase 1 involves qualitative data collection from focus group studies, phase 2 is a randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Impact of structured education on psychological stress to overcome a barrier to injectable treatment for type 2 diabetes: a randomised controlled trial |
| Study objectives | Structured group education delivered before commencement of injectable therapy will alleviate psychological stress thus facilitating improved glycaemic control in adults with type 2 diabetes requiring injectable treatment. |
| Ethics approval(s) | Office of Research Ethics Committees Northern Ireland (ORECNI), 26/05/2015, ref: 15/NI/0091 |
| Health condition(s) or problem(s) studied | Type 2 Diabetes |
| Intervention | Phase 1 Four focus groups, assembled from each of the three study sites, will be explored to inform the development of the content of an education programme. Three of which will be comprised of people who have commenced injectable therapy in the previous 12 months. The other focus group will be comprised of those that have refused to make the transition to injectable therapy in the previous 12 months. A total of 12 diverse participants, selected from the diabetes register (DIAMOND) will be invited by letter to each of the focus groups lasting approximately 1-2 hours. Focus groups comprising of participants that have commenced injectable therapy will be scheduled on each site within a 3 week period. A 4th focus group, will be conducted on the Altnagelvin site within the same time period. The schedules for the groups include questions about barriers experienced and possible strategies to overcome these, any reasons for delay/refusal of treatment, educational tools and resources, timing of sessions in relation to initiation of injectable therapy and post education support. The groups will help to establish beliefs regarding the perceived barriers causing stress, to identify possible strategies to address these issues and their views on how such an education programme should be organised and delivered. An education programme is then designed for phase two of the study, comprising of a evidence based education programme in line with guidelines for diabetes education (NICE, 2008) which will reverse negative attitudes, perceptions and barriers about injection initiation. Phase 2 Potential participants will be identified by the diabetes team from the consultant-led diabetes clinics at Altnagelvin Hospital when a decision has been made that they are to commence injectable therapy. 150 eligible participants with type 2 diabetes from all 3 geographical sites will be randomly allocated to control (usual care) and intervention group (structured group education). Demographic, anthropometric, dietary, clinical including time to commencement of injectable therapy or reasons for further delay or refusal of injections and psychological data will be collected at baseline (recruitment). Additional psychological data will be collected at weeks 12 & 24 post completion of intervention, using the Problem Areas in Diabetes Scale (PAID), the Hospital Anxiety and Depression Scale (HADS-A) and the Pearlin Mastery scale. The PAID Scale has been designed to measure diabetes specific emotional distress and a reduction in this score will form the primary outcome measure. The control group will not receive an education programme but will instead receive an appointment to attend the Diabetes Specialist Nurse to directly commence injectable therapy together with written information on general healthy eating. The intervention group will be informed of the time, date and venue of the next education programme in their locality. Following completion of the programme, each participant will receive an appointment to attend the Diabetes Specialist Nurse to commence injectable therapy. The questionnaires to measure psychological outcomes will be repeated at weeks 12 and 24 for both groups. Data will also be collected at this time regarding dates of initial consultation regarding injectable therapy and subsequent commencement or reasons for delay or refusal. |
| Intervention type | Behavioural |
| Primary outcome measure | Change from baseline between control and intervention group in the Problems Areas in Diabetes Scale (PAID). This will be measured at baseline (week 0 / first contact following consent to participate), week 12 and week 24. |
| Secondary outcome measures | Change from baseline in the Hospital Anxiety and Depression Scale (HADS), the Pearlin Mastery scale, the Diabetes Empowerment Scale - short form (DES-SF), nutritional intake, HbA1c, lipid profile, body weight, BMI. This will be measured at baseline (week 0 / first contact following consent to participate), week 12 and week 24. |
| Overall study start date | 29/09/2014 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Phase 1 1. Type 2 diabetes ≥1 year. 2. Aged between 25 and 75 3. Commencement of insulin or GLP-1 receptor agonist within the previous 12 months from the date of the audit 4. Refusal of insulin or GLP-1 receptor agonist within the previous 12 months from the date of the audit Phase 2 1. Type 2 diabetes diagnosed ≥ 1 year 2. Aged between 25 and 75 3. HbA1c ≥ 58 mmol/mol and ≤90 mmol/mol. 4. Transfer from oral hypoglycaemic treatment to injectable therapy judged appropriate by the consulting physician |
| Key exclusion criteria | Phase 2 1. Newly diagnosed type 2 diabetes < 1 year. 2. Patients who require immediate transfer to injectable therapy 3. HbA1c >90 mmol/mol 4. Patients undergoing retinal photocoagulation therapy or dialysis treatment 5. Those currently in receipt of psychiatry or clinical psychology input 6. Within 3 months of undergoing a major event including MI, stroke and major surgery 7. Within 3 months of diagnosis or treatment of a major coexisting medical condition |
| Date of first enrolment | 03/08/2015 |
| Date of final enrolment | 01/02/2017 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Western Health and Social Care Trust
Clinical Translational Research and Innovation Centre
Altnagelvin Area Hospital
Londonderry
BT47 6SB
United Kingdom
Sponsor information
University/education
Research and Innovation Office
University of Ulster
Jordanstown campus
Shore Road
Newtownabbey
BT37 0QB
Northern Ireland
United Kingdom
Hospital/treatment centre
Research and Development Office
CITRIC
Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
Northern Ireland
United Kingdom
Not defined
| Website | http://www.ulster.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01yp9g959 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the study will be available on the Public Health Agency's Research and Development website. Results will also be reported in a PhD thesis from Ulster University |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/07/2018: The trial end date was changed from 29/09/2017 to 31/12/2018.
