Condition category
Not Applicable
Date applied
20/01/2009
Date assigned
30/01/2009
Last edited
19/12/2012
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

Dr Sue Hall

ORCID ID

Contact details

Department of Palliative Care
Policy & Rehabilitation
Weston Education Centre
Cutcombe Road
London
SE5 9RJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes

Acronym

Study hypothesis

The broad aims of this phase II randomised controlled trial (RCT) are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people in care homes. The specific objectives are to:
1. Determine whether Dignity Therapy is likely to increase peoples' sense of dignity and reduce psychological or spiritual distress
2. Determine whether it is feasible to provide Dignity Therapy to older people in care homes
3. Determine whether Dignity Therapy is acceptable to residents and their families
4. Pilot methods for a larger randomised controlled trial (e.g., recruitment, randomisation, follow-up, suitability of measures)

Ethics approval

Joint South London and Maudsley and the Institute of Psychiatry Research Ethics Committee, approved on 24/11/2008 (ref: 08/H0807/75)

Study design

Phase II randomised controlled open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Ageing: in need of care

Intervention

Dignity Therapy: This is a brief psychotherapy to foster a sense of dignity and reduce psychological and spiritual distress in people reaching the end of life. The therapy involves a therapist conducting an interview with the resident using a standard framework of questions. This is given to residents at least a day before the therapy session to give them the opportunity to think about their responses beforehand. The question framework provides a flexible guide for the therapist to shape the interview, based on patients' level of interest and responses. The therapist follows the residents' cues, helping then to structure and organise their thoughts, for example, by asking questions about time sequences, how events are causally related to each other and facilitating the disclosure of thoughts, feelings and memories. These interviews are tape-recorded, quickly transcribed verbatim then shaped into a narrative using a formatted editing process. This includes clarifications (eliminating colloquialisms, non-starters and sections not related to the "generativity" material, such an interruptions), chronological corrections, tagging and editing any content that might inflict significant harm on recipients of the document (after discussion with the resident) and finding a suitable ending for the document which is appropriate to the residents' overall message. Another session is arranged for the therapist to read the edited transcript to the participants, who are invited to make any editorial suggestions, including identifying errors of omission or commission. Once the resident is satisfied with the document, they can give it, or bequeath it, to people of their choosing. Dignity therapy is given in addition to standard psychological care.

The control group will receive standard psychological care. None of the care homes provide dignity therapy. Information on the nature of standard care is being collected as part of the trial. In addition residents in the control group have at least three interviews with the research assistant. Completing the measures and taking part in the interview gives them an opportunity to talk about their feelings. The extent to which they feel that this is therapeutic is explored in the interviews.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Residents' sense of dignity, assessed using the Patient Dignity Inventory at baseline, 1 and 8 weeks post-intervention, and the equivalent in the control group. Themes covered by this questionnaire include physical, psychosocial, existential and spiritual domains of concern or distress.

Secondary outcome measures

1. Potential effectiveness, assessed at baseline, 1 and 8 weeks post-intervention, and the equivalent in the control group, by the following:
1.1. Geriatric Depression Scale
1.2. Herth Hope Index
1.3. Euroqol EQ-5D
1.4. A two-item measure of quality of life specifically designed to assess the effectiveness of the Dignity Therapy

2. Feasibility, recruitment (residents and their family and friends), assessed at the end of the trial:
2.1. Exclusions, drop-out rates
2.2. Time taken to obtain informed consent and organise and conduct the dignity therapy sessions, transcribe and edit narratives and collect outcomes
2.3. Deviations from the therapy protocol and uncompleted interventions and the reasons for this
2.4. Therapist's perceptions of competence as a result of training

3. Acceptability, assessed by semi-structured interviews with residents to obtain their views on Dignity Therapy (intervention group only) and on taking part in the study (both groups). These qualitative interviews will be conducted before quantitative measures are collected, 1 and 8 weeks post-intervention, and the equivalent in the control group. The therapist records her experiences of delivering the therapy and observations of resident's responses. Case reports will be produced for any difficult cases and, with the consent of participants, a detailed qualitative analysis of the therapy transcripts will be carried out. The latter might provide insight into concerns which might impact on the effectiveness of the intervention.

Overall trial start date

01/12/2008

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Residents (males and females) aged 65 years old or over, living in one of six care homes for older people, are included. Not all residents have a "terminal" illness and they are not selected on the basis of receiving palliative care. However, all residents in nursing homes are frail and could be considered as reaching the end of life. Participants are not screened for spiritual or psychological distress, or loss of dignity, however, these are assessed at baseline, to explore the potential moderating effects of these variables on the impact of the intervention.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Residents who are considered by the care home managers to be too ill to be interviewed
2. Unable to provide informed consent either due to cognitive problems, or to the severity of their illness, or because they are unable to understand English

Recruitment start date

01/12/2008

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Palliative Care, Policy & Rehabilitation
London
SE5 9RJ
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

c/o Prof Robert Lechler
King's College School of Medicine
James Clerk Maxwell Building
London
SE1 8WA
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

The Dunhill Medical Trust (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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21859743

Publication citations

  1. Results

    Hall S, Goddard C, Opio D, Speck P, Higginson IJ, Feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: a phase II randomized controlled trial of a brief palliative care psychotherapy., Palliat Med, 2012, 26, 5, 703-712, doi: 10.1177/0269216311418145.

Additional files

Editorial Notes