Pain Clinical Trial
— LIFEOfficial title:
Legacy Intervention Family Enactment
Verified date | July 2014 |
Source | University of Alabama, Tuscaloosa |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The research activities funded through PAR "Dissemination and Implementation Research in
Health" in grant R21NR011112 "Legacy Intervention Family Enactment (LIFE)" have been varied
and highly successful. The LIFE project was designed with three primary objectives. Aim 1
was to assess the efficacy of LIFE as delivered by Retired Senior Volunteers (RSVs) on
palliative care patients': (a) mood and emotional experience; (b) physical symptom burden;
and (c) experience of meaning. Aim 2 was to assess the efficacy of LIFE as delivered by RSVs
on one primary family caregiver's: (a) caregiving stress; (b) mood and emotional experience;
and (c) experience of positive aspects of caregiving. Aim 3 was to assess the ability of
RSVs to deliver LIFE effectively.
Although hospice and palliative care social workers frequently use reminiscence and creative
activities with their patients 16, such interventions need to be more accessible to patients
and families transitioning from community, hospital, and palliative care settings. If
hospice or palliative care is not chosen as a treatment option, few means of delivering
therapeutic reminiscence-based interventions exist. This represents a significant gap in
practice and in the psychosocial palliative care intervention literature. Kazdin and Blase
(2011) argue cogently that the community need for mental health services far outstrips the
number of providers available to assist those in distress. They call strongly for new
intervention delivery modes targeting prevention and treatment to alleviate suffering.
Hence, the purpose of the present study was to evaluate the effectiveness of retired senior
volunteers (RSVs), who are available nationally through the National Senior Corp Program, to
deliver a three-session reminiscence and creative activity intervention previously found
effective in improving palliative care patient and caregiver outcomes (Allen, 2009; Allen,
Hilgeman, Ege, Shuster, & Burgio, 2008). We hypothesized that palliative care patients and
their caregivers in the RSV-delivered intervention group would demonstrate improved
emotional and spiritual functioning relative to a supportive contact control group. If
successful, this mode of treatment delivery (e.g., RSV intervention) would represent a
significant step toward translation and greater access at earlier disease stages of
therapeutic psychosocial interventions for individuals near the end of life and their family
members.
Status | Completed |
Enrollment | 164 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria for Palliative Care Patients: - Age 55 or older - Living in the community or assisted living - Had an advanced illness or combination of chronic illnesses - Received a score of three or greater on the Vulnerable Elders Scale - Had no more than mild cognitive impairment - Received an average of four hours per week of care from a caregiver - Read and spoke English. Inclusion Criteria for Palliative Caregivers: - Identified by an eligible palliative care patient - Age 19 or older - Providing an average of four hours per week of care for the patient - Cognitively intact - Lived nearby - Read and spoke English. Inclusion Criteria for Retired Senior Volunteers: - Participants in the national Senior Corp program - Had a high school education - Read and spoke English - Had a car and drove independently. Exclusion Criteria for patient-caregiver dyads: - If the patient was receiving hospice care - If either individual had schizophrenia or bipolar disorder - If the patient had a nursing home admission planned within three months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | The University of Alabama, Tuscaloosa | Tuscaloosa | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama, Tuscaloosa | National Institute of Nursing Research (NINR) |
United States,
Allen RS, Harris GM, Burgio LD, Azuero CB, Miller LA, Shin HJ, Eichorst MK, Csikai EL, DeCoster J, Dunn LL, Kvale E, Parmelee P. Can senior volunteers deliver reminiscence and creative activity interventions? Results of the legacy intervention family enac — View Citation
Harris GM, Allen RS, Dunn L, Parmelee P. "Trouble won't last always": religious coping and meaning in the stress process. Qual Health Res. 2013 Jun;23(6):773-81. doi: 10.1177/1049732313482590. Epub 2013 Mar 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Brief Multidimensional Measure of Religiousness and Spirituality (BMMRS) | This study examined patient: Forgiveness (3 items; a = 0.75) asking how often the patient has forgiven themselves, others, or experienced God's forgiveness. Higher scores indicate greater frequency of forgiveness. One item dealt with religious struggle: "I wonder whether God has abandoned me". Higher scores indicate greater agreement with the item. Two items measure Religious Meaning: "The events in my life unfold according to a divine or greater plan" and "I have a sense of mission or calling in my own life" (a = 0.64). Higher scores indicate greater agreement with the items. | Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later) | No |
Primary | Change in Memorial Symptom Assessment Scale-Short Form | Patients and caregivers independently rated the patient's physical and psychological symptoms and associated distress. Higher scores in the symptom category indicate the presence of more patient symptoms while higher bother scores indicate greater patient distress related to symptoms. Cronbach's alpha coefficients for the MSAS-SF subscales range from.76 to .87. | Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later) | No |
Secondary | Change in Meaning in Life | This eight-item scale assessed four domains values, purpose, goals, and reflections. Higher scores indicate greater meaning. Cronbach's alpha = .856. | Pre-Post Intervention (up to 20 weeks after baseline) and Follow-Up (up to 14 weeks later) | No |
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