Clinical trial NCT00735800: Telephone Support for Dementia Caregivers
Official title: Psychosocial Telephone Intervention for Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Keywords: Dementia
Caregivers
Alzheimer's disease
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2008-08-15
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress.

Detailed description: A previous pilot study of this approach showed reduced burden and reaction to memory and behavior problems for dementia caregivers. This study will test the intervention in a larger group of caregivers and have a more detailed analysis of outcomes.

The caregiver of a person with dementia will receive telephone support calls. They will receive telephone calls from a trained member of the research team. These calls will occur over a six-month period and will be scheduled at a time that is convenient for the caregiver. They will receive a total of 16 calls over 6 months. During each call, the support person will discuss their current caregiving situation and provide various forms of support.

Eligibility criteria: Inclusion Criteria:

* 1) Diagnosis of dementia;
* 2) mild to moderate dementia;
* 3) family member or other adult in caregiver role for at least 6 months, and who provides at least 4 hours of supervision or direct assistance per day for the person with dementia;
* 4) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
* 5) there is no plan for the care recipient to be placed in long term care or the caregiver to end their role within the next 6 months

Exclusion Criteria:

Patient:

* 1) other major medical condition affecting independent functioning
* 2) older than age 90; and
* 3) younger than age 50.

Caregiver:

* 1) major acute medical illness;
* 2) English not primary language;
* 3) cognitive impairment;
* 4) no access to a telephone; or
* 5) older than age 90.

Primary outcomes:
measure: Depression, burden, reaction to memory and behavior problems
timeFrame: Every two months, over a 6 month time-period , and a three month follow-up
Secondary outcomes:
measure: Cost-effectiveness and resource use
timeFrame: Monthly resource check-ins.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Geoffery Tremont, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruce JM, McQuiggan M, Williams V, Westervelt H, Tremont G. Burden among spousal and child caregivers of patients with mild cognitive impairment. Dement Geriatr Cogn Disord. 2008;25(4):385-90. doi: 10.1159/000122587. Epub 2008 Mar 29.
citation: Davis JD, Tremont G. Impact of frontal systems behavioral functioning in dementia on caregiver burden. J Neuropsychiatry Clin Neurosci. 2007 Winter;19(1):43-9. doi: 10.1176/jnp.2007.19.1.43.
citation: Epstein-Lubow G, Davis JD, Miller IW, Tremont G. Persisting burden predicts depressive symptoms in dementia caregivers. J Geriatr Psychiatry Neurol. 2008 Sep;21(3):198-203. doi: 10.1177/0891988708320972.
citation: Spitznagel MB, Tremont G, Davis JD, Foster SM. Psychosocial predictors of dementia caregiver desire to institutionalize: caregiver, care recipient, and family relationship factors. J Geriatr Psychiatry Neurol. 2006 Mar;19(1):16-20. doi: 10.1177/0891988705284713.
citation: Steadman PL, Tremont G, Davis JD. Premorbid relationship satisfaction and caregiver burden in dementia caregivers. J Geriatr Psychiatry Neurol. 2007 Jun;20(2):115-9. doi: 10.1177/0891988706298624.
citation: Tremont G, Davis JD, Bishop DS. Unique contribution of family functioning in caregivers of patients with mild to moderate dementia. Dement Geriatr Cogn Disord. 2006;21(3):170-4. doi: 10.1159/000090699. Epub 2006 Jan 3.
citation: Tremont G, Davis JD, Bishop DS, Fortinsky RH. Telephone-Delivered Psychosocial Intervention Reduces Burden in Dementia Caregivers. Dementia (London). 2008;7(4):503-520. doi: 10.1177/1471301208096632.