Condition category
Mental and Behavioural Disorders
Date applied
26/06/2012
Date assigned
26/06/2012
Last edited
05/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.bristol.ac.uk/healthlines/

Contact information

Type

Scientific

Primary contact

Prof Chris Salisbury

ORCID ID

http://orcid.org/0000-0002-4378-3960

Contact details

Centre for Academic Primary Care
School of Social and Community Medicine
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
-
c.salisbury@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12516

Study information

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

Acronym

Study hypothesis

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

NRES Committee South West - Frenchay, 07/02/2012, REC ref: 12/SW/0009

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

11/06/2012

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

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)

Participant 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.

Recruitment start date

06/07/2012

Recruitment end date

01/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Academic Primary Care
Bristol
BS8 2PS
United Kingdom

Trial participating centre

School of Health and Related Research (ScHARR)
University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24460845
2015 substudy results in: http://www.ncbi.nlm.nih.gov/pubmed/26187378
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26044763
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26912230
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27132075

Publication citations

  1. Protocol

    Thomas CL, Man MS, O'Cathain A, Hollinghurst S, Large S, Edwards L, Nicholl J, Montgomery AA, Salisbury C, Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials., Trials, 2014, 15, 36, doi: 10.1186/1745-6215-15-36.

  2. Results

    Man MS; Healthlines Study Group, Rick J, Bower P; MRC-START Group, Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials, Trials, 2015, 16, 1, 309, doi: 10.1186/s13063-015-0820-0.

  3. Results

    Foster A, Horspool KA, Edwards L, Thomas CL, Salisbury C, Montgomery AA, O'Cathain A, Who does not participate in telehealth trials and why? A cross-sectional survey, Trials, 2015, 16, 258, doi: 10.1186/s13063-015-0773-3.

  4. Results

    Edwards L, Salisbury C, Horspool K, Foster A, Garner K, Montgomery AA, Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies, Trials, 2016, 17, 1, 107, doi: 10.1186/s13063-016-1234-3.

  5. Results

    Salisbury C, O'Cathain A, Edwards L, Thomas C, Gaunt D, Hollinghurst S, Nicholl J, Large S, Yardley L, Lewis G, Foster A, Garner K, Horspool K, Man MS, Rogers A, Pope C, Dixon P, Montgomery AA, Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention, Lancet Psychiatry, 2016 , pii: S2215-0366(16)00083-3, doi: 10.1016/S2215-0366(16)00083-3.

Additional files

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.