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A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: study protocol.

A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: study protocol.
A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: study protocol.
Background: although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT.
Methods/design: a randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method.
Discussion: Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.
Trial registration: Current Controlled Clinical Trials: ISRCTN37589515
1471-2318
8pp
Hall, Sue
0fd070f4-6194-49fc-9a91-98e3cbbdfeaa
Chochinov, Harvey
b296aefe-8f9c-4382-9a09-c7f046d1ceab
Harding, Richard
dcc93e32-38c2-4db1-ab29-078405b9572e
Murray, Scott
6267ffdd-e6c1-41d1-a50a-bd61c639ae6d
Richardson, Alison
3db30680-aa47-43a5-b54d-62d10ece17b7
Higginson, Irene J.
8bff8e06-57f3-491b-ab81-2ecf983f52f3
Hall, Sue
0fd070f4-6194-49fc-9a91-98e3cbbdfeaa
Chochinov, Harvey
b296aefe-8f9c-4382-9a09-c7f046d1ceab
Harding, Richard
dcc93e32-38c2-4db1-ab29-078405b9572e
Murray, Scott
6267ffdd-e6c1-41d1-a50a-bd61c639ae6d
Richardson, Alison
3db30680-aa47-43a5-b54d-62d10ece17b7
Higginson, Irene J.
8bff8e06-57f3-491b-ab81-2ecf983f52f3

Hall, Sue, Chochinov, Harvey, Harding, Richard, Murray, Scott, Richardson, Alison and Higginson, Irene J. (2009) A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: study protocol. BMC Geriatrics, 9 (9), 8pp. (doi:10.1186/1471-2318-9-9).

Record type: Article

Abstract

Background: although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT.
Methods/design: a randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method.
Discussion: Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.
Trial registration: Current Controlled Clinical Trials: ISRCTN37589515

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Published date: March 2009

Identifiers

Local EPrints ID: 69381
URI: http://eprints.soton.ac.uk/id/eprint/69381
ISSN: 1471-2318
PURE UUID: dc6cd5ec-408a-46e3-b8a1-9fa2cb02eaa0
ORCID for Alison Richardson: ORCID iD orcid.org/0000-0003-3127-5755

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Date deposited: 10 Nov 2009
Last modified: 12 Nov 2019 01:42

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