Healthlines Randomised Controlled Trial - Depression
| ISRCTN | ISRCTN14172341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14172341 |
| Secondary identifying numbers | 12516 |
- Submission date
- 26/06/2012
- Registration date
- 26/06/2012
- Last edited
- 05/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
As the population ages, more and more people are suffering from long-term conditions (LTCs). Health services around the world are exploring new ways of supporting these people and there is great interest in the use of telehealth: technologies such as the internet, phone, text messaging and home self-monitoring. This study aims to evaluate the effectiveness and cost-effectiveness of a NHS Direct-delivered telehealth intervention to support patients with depression.
Who can participate?
Patients aged 18 and older will be recruited from 34 general practices near Bristol, Sheffield and Southampton. Patients will be identified using practice record searches or by direct referral by practice staff. To be eligible, patients need to have depression confirmed by assessment using a validated questionnaire, and must have access to a telephone, the internet and an email address for personal use.
What does the study involve?
Patients will complete further questionnaires, and then be randomly allocated to one of two groups. At 4, 8 and 12 months patients will be asked to complete more questionnaires. The two groups in the study are:
1. Usual care: care provided by GP or nurse at usual general practice as required.
2. Usual care plus NHS Direct Healthlines: usual care, plus extra support provided by NHS Direct by telephone, email and internet, including regular contact to provide advice and encouragement and access to tailored online resources.
What are the possible benefits and risks of participating?
The trial will be helpful in planning future services to be delivered by the NHS, which may benefit future patients. Participants may personally benefit from taking part by learning more about their own health, how to manage it, and having regularly scheduled health checks. As a result, their own health and well-being might improve. Participants in research have to give up some of their own time, which may not appeal to everyone. They may feel uncomfortable answering some questions over the phone. However, the depression screening questions are from a standard questionnaire, which is designed to collect information about symptoms rather than personal circumstances. Collecting this information is necessary for participation, but if this is too distressing, patients may ask us to phone on another occasion or can withdraw from the study. We do not anticipate any other risks associated with taking part in this study.
Where is the study run from?
The study is led by the University of Bristol, in collaboration with the Universities of Sheffield, Southampton and Manchester, and NHS Direct.
When is the study starting and how long is it expected to run for?
Recruiting patients to the trial starts in July 2012 and is expected to end in February 2013, with further follow-up of participants continuing until March 2014.
Who is funding the study?
National Institute of Health Research (NIHR) (UK)
Who is the main contact?
Chris Salisbury
c.salisbury@bristol.ac.uk
Contact information
Scientific
Centre for Academic Primary Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-4378-3960 |
|---|---|
| c.salisbury@bristol.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| 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 | Effectiveness and cost-effectiveness of an NHS Direct-delivered telehealth intervention to support the management of long term conditions: a pragmatic randomised controlled trial for patients with depression |
| Study objectives | As the population ages, more and more people are suffering from long-term conditions (LTCs). Health services around the world are exploring new ways of supporting these people and there is great interest in the use of telehealth: technologies such as the internet, phone, text messaging and home self-monitoring. This study aims to evaluate the effectiveness and cost-effectiveness of a NHS Direct-delivered telehealth intervention to support patients with LTCs. A randomised controlled trial will be conducted with 640 patients with depression as an exemplar LTC. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12516 Added 26/04/2013: Sub-study title Systematic Techniques for Assisting Recruitment to Trials in Healthlines (MRC START in Healthlines) The MRC START sub-study sits within the existing Healthlines trials study design. MRC START in Healthlines is a 'nested' RCT. Potential participants in the Healthlines trials will be randomised to MRC START to receive either the standard or the user tested versions of the Healthlines participant information sheets and covering letters. Sub-study aims 1. To establish if the numbers of patients recruited in to the Healthlines Trials are increased by the use of a participant information sheet and covering letter developed through a process of 'User Testing', compared to a routine participant information sheet. 2. To explore whether user testing of the PIS and covering letter improves retention in the Healthlines Trials host studies. |
| Ethics approval(s) | NRES Committee South West - Frenchay, 07/02/2012, REC ref: 12/SW/0009 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases |
| Intervention | Current interventions as of 26/04/2013: Usual Care: Care provided by GP or nurse at usual general practice as required. Usual Care plus NHS Direct Healthlines: Usual Care, plus extra support provided by NHS Direct by telephone, email and internet, including regular contact to provide advice and encouragement and access to tailored online resources. Primary follow up is at 4 months, with further follow up at 8 and 12 months. Follow Up Length: 12 month(s) Sub-study: Patients who are being invited to participate in the Healthlines trial will be randomly allocated to one of two interventions 1. Sent the original Healthlines trial participant information sheet and covering letter 2. Sent the user tested participant information sheet and covering letter Previous interventions until 26/04/2013: Usual Care: Care provided by GP or nurse at usual general practice as required. Usual Care plus NHS Direct Healthlines: Usual Care, plus extra support provided by NHS Direct by telephone, email and internet, including regular contact to provide advice and encouragement and access to tailored online resources. Primary follow up is at 4 months, with further follow up at 8 and 12 months. Follow Up Length: 12 month(s) |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 26/04/2013: 1. Patient Health Questionnaire (PHQ)-9 Depression Score <10 AND an absolute reduction in PHQ-9 of at least 5 points after 4 months 2. (Sub-study only) The number of patients consenting to participate in the Healthlines Trials. Previous primary outcome measures until 26/04/2013: Patient Health Questionnaire (PHQ)-9 Depression Score <10 AND an absolute reduction in PHQ-9 of at least 5 points after 4 months |
| Secondary outcome measures | Current secondary outcome measures as of 26/04/2013: 1. PHQ-9 score as continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Use of telehealth interventions 7. Self management skills 8. Self efficacy 9. Medication adherence 10. Health literacy; anxiety 11. Care coordination 12. (Sub-study only) Retention in the Healthlines studies. We will keep a record of all patients who were identified as potential participants and which intervention group they were in. Previous secondary outcome measures until 26/04/2013: 1. PHQ-9 score as continuous variable 2. Quality of life (EQ-5D-5L) 3. Patient satisfaction 4. Patient perceived access to care 5. Exercise behaviour 6. Use of telehealth interventions 7. Self management skills 8. Self efficacy 9. Medication adherence 10. Health literacy; anxiety 11. Care coordination |
| Overall study start date | 11/06/2012 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 640; UK Sample Size: 640; Description: 40 run-in phase participants (30 intervention, 10 controls)600 main trial participants (300 intervention, 300 control) |
| Key inclusion criteria | 1. Target Gender: Male & Female; Upper Age Limit 100 years; Lower Age Limit 18 years (on date of invitation to participate) 2. Confirmed diagnosis of depression using the Clinical Interview Schedule 3. Revised (CIS-R) and PHQ-9 = 10 4. Access to a telephone (landline or mobile), the Internet and an e-mail address for personal use |
| Key exclusion criteria | 1. Currently receiving case management from a specialist mental health worker 2. Currently receiving face-to-face, telephone or computerised CBT or similar psychotherapy 3. Have given birth in the previous 12 months 4. Bipolar disorder 5. Psychotic illness 6. Dementia or substantial cognitive impairment 7. Severe learning disability 8. Substance dependency 9. Receiving palliative care 10. Significant suicidal risk 11. GP determines that participation would cause distress (e.g. due to recent bereavement) 12. Inability to communicate verbally in English sufficiently to receive telephone-based support delivered in English. Patients who can communicate verbally in English but are unable to read English will be eligible provided they have a family member or friend who is willing and able to translate written materials (such as information sheets, consent forms and online material) for them. |
| Date of first enrolment | 06/07/2012 |
| Date of final enrolment | 01/02/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
BS8 2PS
United Kingdom
Sheffield
S1 4DA
United Kingdom
Sponsor information
University/education
Research and Enterprise Development
3rd Floor, Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Website | http://www.bristol.ac.uk/red/ |
|---|---|
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
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 | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results of the trial and the economic evaluation will be published in due course, as a full report from NIHR and as academic journal articles. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/01/2014 | Yes | No | |
| Results article | results | 05/06/2015 | Yes | No | |
| Results article | substudy results | 19/07/2015 | Yes | No | |
| Results article | results | 24/02/2016 | Yes | No | |
| Results article | results | 01/06/2016 | Yes | No |
Editorial Notes
05/05/2016: Publication reference added.
26/02/2016: Publication references added.
26/04/2013: the overall trial end date was changed from 28/02/2013 to 31/07/2013.
