Telephone Support for Dementia Caregivers

Dementia Clinical Trial

Official title:

Psychosocial Telephone Intervention for Dementia Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735800
• Other study ID #: R01NR010559
• Secondary ID: R01NR010559
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2008
• Last updated: May 4, 2015
• Start date: February 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2015
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• Family Intervention:Telephone Tracking Support- Caregiver
Family-based problem solving treatment
• Telephone Support
Supportive telephone counseling about caregiving

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2006 Jan 3. — View Citation

Tremont, G., Davis, J.D., Bishop, D.S., & Fortinsky, R.H. (in press). Telephone-Delivered psychosocial intervention reduces burden in dementia caregivers. Dementia: The International Journal of Social Research and Practice.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression, burden, reaction to memory and behavior problems		Every two months, over a 6 month time-period , and a three month follow-up	No
Secondary	Cost-effectiveness and resource use		Monthly resource check-ins.	No

External Links

•   Link to study webpage