Efficacy of Early Stage Alzheimer's Support Groups

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of an Early Stage Memory Loss Support Group (ESSG) and Education Seminar (ES) on quality of life, mood, social support, distress about memory loss, and interpersonal relationships of memory loss participants and their caregivers.

Detailed Description
-----------------
With recent advances in diagnostic procedures and treatment options, many individuals with AD are now diagnosed early in the disease. Early diagnosis has many benefits: treatment can be started sooner, legal and financial planning can be addressed while the individual is able to participate in decision-making, and support services can be mobilized earlier. However, early diagnosis may also have negative consequences for the diagnosed individual's quality of life. Thus, diagnosis creates an obligation to help individuals and their families learn more about AD and cope with the impact of the diagnosis. Many Alzheimer's Association chapters have begun providing early stage support groups that focus on enhancing quality of life for participants and their caregivers. Anecdotal reports suggest that these groups improve quality of life of participants, but some individuals may also experience decreases in quality of life associated with stress, depression, or family conflict as a result of discussing current and future losses in the group. Thus, there is a need to systematically evaluate the benefits of these groups. This study will evaluate and compare the efficacy of a structured, 8-session Early Stage Support Group intervention (ESSG) and a half-day Education Seminar (ES). Participants with early stage memory loss and their caregivers will be randomly assigned to either ESSG or ES. Both are presented by the Alzheimer's Association Western & Central Washington State Chapter.

Official Title
-----------------
Efficacy of Early Stage Alzheimer's Support Groups

Conditions
-----------------
Memory Loss, Alzheimer's Disease, Dementia

Intervention / Treatment
-----------------
* Behavioral: Early Stage Memory Loss Support Group
* Behavioral: Educational Seminar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dementia diagnosis confirmed by primary care physician Early stage dementia, defined as a Mini Mental State Exam score of 18 or higher, and a Clinical Dementia Rating of 1 or less Care partner who will attend groups and complete study assessments Aware of memory loss (verbally acknowledges memory loss and/or expresses concern about memory) Comfortable in a group separate from family members No significant history of mental illness (no hospitalization or medication for psychotic disorder within the past 2 years) Consent to research participation (participant, care partner, legal representative) Remain in the community for the 6 month duration of the study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESSG<br>eight weekly 90-minute sessions | Behavioral: Early Stage Memory Loss Support Group<br>* 8 week support group led by trained facilitators<br>* Other names: ESSG;|
| Active Comparator: ES<br>one 4-hour educational program | Behavioral: Educational Seminar<br>* 4 hour education session led by trained facilitators<br>* Other names: ES;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  | baseline, 3 months, and 6 months | 
| Social support |  | baseline, 3 months, and 6 months | 
| Family Relationships |  | baseline, 3 months, and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Memory, Alzheimer's disease, Dementia, Support Group, Psychosocial