Condition category
Signs and Symptoms
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
08/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Shashivadan Hirani

ORCID ID

Contact details

Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
s.hirani@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4635

Study information

Scientific title

Acronym

WSD

Study hypothesis

The care of individuals with long-term conditions (such as heart failure and diabetes) and those who need help from social care services (such as frail older people) is very important. The government wants to improve services for these people, by helping health and social care services to work together more effectively. It is hoped that this will lead to better outcomes, with people able to live at home longer, reducing the risk of ill health and providing more support for informal carers. To make this possible, it is also important that these new services do not increase costs.

The Whole System Demonstrator Project:
In a government initiative known as the Whole System Demonstrator project (WSD), it is planned to help health and social services to work together by introducing new technologies into three pilot sites (Cornwall, Kent and Newham). These technologies fall into two general groups:
1. Telecare packages monitor people in their homes and send alerts when required, e.g., sensors to detect falls
2. Telehealth interventions will allow people to communicate at a distance with their health care professional (e.g. sending blood glucose results)

Evaluation:
Although these technologies have been evaluated, published evaluations have been small and insufficiently rigorous. At present it is not clear whether these new technologies are effective and a good use of public money. We intend to test the value of these technologies using a number of different research methods. To achieve this we are using a randomised controlled trial to compare patients using these new technologies with those who receive usual care. We will also use qualitative studies to examine other issues in more detail.

Ethics approval

MREC approved (ref: 08/H1005/4)

Study design

Multicentre randomised interventional process of care trial with qualitative component

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

1. Telecare assistive devices: Telecare assistive devices and support for individuals receiving social care, controls will receive usual care
2. Telehealth assistive devices: Telehealth assistive devices and support for individuals with long term condition (heart failure, chronic obstructive pulmonary disease [COPD] and diabetes)
3. Control: controls will receive usual care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 36-item Short Form Health Survey (SF-36)
2. EuroQoL questionnaire (EQ-5D)
3. Generic heart-failure, diabetes and COPD quality of life (QoL) questionnaires
4. Center for Epidemiologic Studies Depression Scale (CES-D)
5. 6-Item Short-Form of the State Scale of the Spielberger State Trait Anxiety Inventory (STAI-6)

All measured at 3 and 12 months.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2008

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

The eligibility criteria for the trial have been broadly determined by the policy focus of the funder, the Department of Health, on people with long term conditions and social care needs. They have been reached through discussions with both the Department of Health and the three participating sites. They have also been derived partly from existing evidence about which populations are mostly likely to benefit from the delivery of telecare and telehealth devices but also maximise reliance on professional judgement about which groups are most likely to benefit.

Detailed inclusion criteria:
Individuals aged 18 years or over fulfilling criteria A and B:

Criteria A:
At least one of three long-term index conditions as defined using Quality and Outcomes Framework (QOF) criteria:
1. Heart failure: diagnosis confirmed by echocardiogram or by specialist assessment
2. Diabetes: those with a diagnosis of Type 1 or Type 2 diabetes and:
2.1. A recorded HbA1c in the previous 15 months
2.2. Excluding those in whom the last HbA1c is 7.4 or less
3. Chronic obstructive pulmonary disease (COPD): diagnosis confirmed by spirometry (COPD is diagnosed if the individual has a forced expiratory volume in one second [FEV1] of less than 70% of predicted normal and has an FEV1/forced vital capacity [FVC] ratio less than 70%)
4. Additional physical co-morbidities may be present; these individuals will still be eligible

Criteria B:
5. At least one unplanned admission to hospital relating to their long term
condition(s)in the previous year, or has had at least one episode of care in the past year from intermediate care services, rapid response services, ambulance services, Accident and Emergency relating to their long term condition
6. Individuals aged 18 years and over with social care needs who would benefit from telecare. They must meet one or more of the following criteria:
6.1. Currently in receipt of, or considered to have a need for night sitting
6.2. Receiving 7 or more hours per week of home care or 3.5 or more hours per week of home care plus a meals service (defined by individual not household)
6.3. Receiving 1 or more days per week of day care
6.4. Have had a fall or who are considered at high risk of falling
6.5. A live-in or nearby informal carer facing difficulties carrying their current burden of responsibilities
6.6. Cognitive impairment/confusion (people fulfilling this criterion who are unable to provide written informed consent and do not have a primary informal caregiver available or an advocate will not be approached to participate in the questionnaire study)

The following definition of an informal carer will be used:
Someone who is seeing and helping their family member, relative or friend at least once a week.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 6000; UK sample size: 6000

Participant exclusion criteria

General exclusion criteria:
1. Lack of ability to understand English (the devices are not currently tailored to support non-English language speakers)
2. Inability to complete the questionnaire with support from a researcher (applies to questionnaire study only - Themes 2 and 3)

Telehealth exclusion criteria:
3. People with one or more of the three index conditions (above) and cognitive impairment/confusion but insufficient informal caregiver support available to enable regular readings to be taken using telehealth equipment. This group will still be eligible to receive telecare.
4. Individuals without an appropriate power supply or telephone line in their place of residence (Telehealth requires an appropriate power supply or telephone line so if this is not available it cannot be installed)
5. Telehealth already installed (this exclusion criteria is likely to only apply to the Kent site where some pilot work has already been undertaken with telehealth equipment - individuals who already have telehealth equipment will need to be excluded to reduce learning effects)

Telecare exclusion criteria:
6. Telecare already installed (excluding pendant alarms)

Recruitment start date

01/05/2008

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charles Bell House
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Policy Research Programme
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21819569
2012 secondary care and mortality results in: http://www.ncbi.nlm.nih.gov/pubmed/22723612
2013 cost-effectiveness in: http://www.ncbi.nlm.nih.gov/pubmed/23520339
2013 health and social care services results in: http://www.ncbi.nlm.nih.gov/pubmed/23443509
2013 general practice contacts results in: http://www.ncbi.nlm.nih.gov/pubmed/24099334
2013 quality of life results in: http://www.ncbi.nlm.nih.gov/pubmed/24333802
2014 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/24950690
2014 type 2 diabetes results in: http://www.ncbi.nlm.nih.gov/pubmed/25100190

Publication citations

  1. Protocol

    Bower P, Cartwright M, Hirani SP, Barlow J, Hendy J, Knapp M, Henderson C, Rogers A, Sanders C, Bardsley M, Steventon A, Fitzpatrick R, Doll H, Newman S, A comprehensive evaluation of the impact of telemonitoring in patients with long-term conditions and social care needs: protocol for the whole systems demonstrator cluster randomised trial., BMC Health Serv Res, 2011, 11, 184, doi: 10.1186/1472-6963-11-184.

  2. Secondary care and mortality results

    Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Hirani S, Cartwright M, Rixon L, Knapp M, Henderson C, Rogers A, Fitzpatrick R, Hendy J, Newman S, , Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial., BMJ, 2012, 344, e3874.

  3. Health and social care services results

    Steventon A, Bardsley M, Billings J, Dixon J, Doll H, Beynon M, Hirani S, Cartwright M, Rixon L, Knapp M, Henderson C, Rogers A, Hendy J, Fitzpatrick R, Newman S, Effect of telecare on use of health and social care services: findings from the Whole Systems Demonstrator cluster randomised trial., Age Ageing, 2013, 42, 4, 501-508, doi: 10.1093/ageing/aft008.

  4. General practice contacts results

    Bardsley M, Steventon A, Doll H, Impact of telehealth on general practice contacts: findings from the whole systems demonstrator cluster randomised trial., BMC Health Serv Res, 2013, 13, 395, doi: 10.1186/1472-6963-13-395.

  5. Quality of life results

    Hirani SP, Beynon M, Cartwright M, Rixon L, Doll H, Henderson C, Bardsley M, Steventon A, Knapp M, Rogers A, Bower P, Sanders C, Fitzpatrick R, Hendy J, Newman SP, The effect of telecare on the quality of life and psychological well-being of elderly recipients of social care over a 12-month period: the Whole Systems Demonstrator cluster randomised trial., Age Ageing, 2014, 43, 3, 334-341, doi: 10.1093/ageing/aft185.

  6. Henderson C, Knapp M, Fernández JL, Beecham J, Hirani SP, Cartwright M, Rixon L, Beynon M, Rogers A, Bower P, Doll H, Fitzpatrick R, Steventon A, Bardsley M, Hendy J, Newman SP, , Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial., BMJ, 2013, 346, f1035.

  7. Henderson C, Knapp M, Fernández JL, Beecham J, Hirani SP, Beynon M, Cartwright M, Rixon L, Doll H, Bower P, Steventon A, Rogers A, Fitzpatrick R, Barlow J, Bardsley M, Newman SP, Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial., Age Ageing, 2014, doi: 10.1093/ageing/afu067.

  8. Steventon A, Bardsley M, Doll H, Tuckey E, Newman SP, Effect of telehealth on glycaemic control: analysis of patients with type 2 diabetes in the Whole Systems Demonstrator cluster randomised trial., BMC Health Serv Res, 2014, 14, 334, doi: 10.1186/1472-6963-14-334.

Additional files

Editorial Notes