REACH Steering Committee Conference Call
Wednesday, December 12, 2001
12:00 - 1:00 Eastern
Agenda
Teleconference Number: 1-888-271-0949
Participant Code: 852384
- Workgroup Reports
· Recruitment and Retention – Bob Burns (see proposed inclusion/exclusion criteria, prescreen, screen, recruitment strategies included in this attachment)
· Measurement – Rich Schulz
· Risk Appraisal – Laura Gitlin
· Intervention – Laura Gitlin
- P & P Activities
· Reminder about deadline for site-specific major outcome papers – Sara Czaja
· Psych and Aging paper update – Rich Schulz
· GT Review paper update – Rich Schulz
· Paying Bill Haley – Rich Schulz
- Agenda for January Steering Committee meeting (see agenda included in this attachment)
- NIA Report – Sid Stahl
· Update on DSMB
· Update on carryover money
- NACDA public database – Rich Schulz
- Schedule future SC conference calls?
Recruitment and Retention Workgroup
These are the action items generated at the October Steering Committee meeting for the R&R Workgroup. The workgroup is ready to present the first four items to the Steering Committee for discussion and approval and update the last item.
· Develop screening tool based on the risk appraisal and primary outcome
· Determine entry criteria
· Review information on Federal Wide Assurance; develop general guidelines for sites
· Generate a menu of recruitment strategies
· Discuss public relations material
1. Risk Screening Tool
DRAFT
Now I would like to ask you a few questions about you.
Caregivers are often so concerned with caring for their relative’s needs that they lose sight of their own well-being. Please take just a moment to answer the following questions.
1. Had trouble keeping my mind on what I was doing. Yes No
2. Felt completely overwhelmed. Yes No
3. Been edgy or irritable. Yes No
4. Had back pain. Yes No
5. On a scale of 1 to 10, with 1 being “not stressful” to 10 being “extremely
stressful,” please rate your current level of stress. ______
Is the score 6 or higher? Yes No
6. On a scale of 1 to 10, with 1 being “very healthy” to 10 being “very ill,”
please rate your current health compared to what it was this time last year. ______
Is the score 6 or higher? Yes No
Total Yes Score______
Did the caregiver have a total score of 2 or more? Yes No
If yes, continue to question 7, if no exclude.
Now I’d like to ask you about some of the problems you may have encountered while caring for (CR). I will read a list of specific problems participants sometimes have. Please indicate if any of these problems have occurred during the past week. If so, how much has this bothered or upset you when it happened.7. / Within the past week, has (CR) been experiencing any memory problems? Such as asking the same question over and over, forgetting what day it is, or losing or misplacing things?
No / Yes / Unknown / Refused
0 ( ) / 1 ( ) / -3 ( ) / -4 ( )
7.1 / How bothered or upset were you by this? Possible responses are listed on this card.
Not at all / A little / Moderately / Very much / Extremely /
Unknown
/ Refused0 ( ) / 1 ( ) / 2 ( ) / 3 ( ) / 4 ( ) / -3 ( ) / -4 ( )
8. / Within the past week, has (CR) been experiencing any behavior problems? Such as arguing, being irritable, verbally aggressive or waking you or other family members up at night?
No / Yes / Unknown / Refused
0 ( ) / 1 ( ) / -3 ( ) / -4 ( )
8.1 / How bothered or upset were you by this?
Not at all / A little / Moderately / Very much / Extremely /
Unknown
/ Refused0 ( ) / 1 ( ) / 2 ( ) / 3 ( ) / 4 ( ) / -3 ( ) / -4 ( )
9. / Within the past week, has (CR) appeared anxious or worried, sad or depressed or had crying spells?
No / Yes / Unknown / Refused
0 ( ) / 1 ( ) / -3 ( ) / -4 ( )
9.1 / How bothered or upset were you by this?
Not at all / A little / Moderately / Very much / Extremely / Unknown / Refused
0 ( ) / 1 ( ) / 2 ( ) / 3 ( ) / 4 ( ) / -3 ( ) / -4 ( )
Did the caregiver have a total score of 2 with some level of bother on one
of the three domains? Yes No
If yes, continue to next question, if no exclude.
2. Entry Criteria. Dolores made the suggestion to remove the “living with caregiver “ as an inclusion criterion. Bob suggested it should stay due to methodological issues that would arise with a different population. The vote by the work group to remove “living with” was three to two with Miami suggesting that there could be a mileage range of living apart. The group voted to move this discussion to the Steering Committee.
Caregiver Inclusion/Exclusion
Inclusion criteria:
1. At least 21 years old
2. A family member of the care recipient
3. Must live with the care recipient or share cooking facilities
4. Must have a telephone
5. Must plan to remain in the area for the duration of the intervention and follow-up
6. Must have been a caregiver for more than 6 months
7. Must provide on average 4 hours of supervision or direct assistance per day for the care recipient
8. Must be at risk with bother of 2 or greater on 1 of the three domains and 2 or more on the caregiver distress scale
Exclusion criteria:
1. Any terminal illness with life expectancy of less than 6 months
2. Active treatment (chemotherapy or radiation therapy) for cancer
3. Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
4. Involvement in another clinical trial for caregivers
5. Miscellaneous barriers such as transportation, commitment, hesitancy, etc.
Care Recipient Inclusion/Exclusion Criteria
Inclusion criteria:
1. NINCDS (MD diagnosis) or cognitive impairment (raw score on MMSE of 23 or less)
Exclusion criteria:
1. Any terminal illness with life expectancy of less than 6 months
2. Active treatment (chemotherapy or radiation therapy) for cancer
3. More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer’s Disease related admissions)
4. Schizophrenia or other mental illness (to be defined more in Q by Q’s)
5. Dementia secondary to head trauma
6. Blindness or deafness if either disability prohibits them from data collection or participation in the interventions
7. MMSE = 0 and Bedbound (as defined in MSD) of more than 22 hours
8. Planned nursing home admission in 6 months
3. The Pre-Screen. Please note that number 3 (Living with) will reflect the vote of the Steering Committee.
D-R-A-F-T
1. The REACH program is focusing on African American, White and Hispanic caregivers. Do you identify yourself with any of these groups?
No 0 ( )
Yes 1 ( ) (indicate which group by circling)
If necessary: Which group do you identify with? (indicate which group by circling above)
If YES, proceed with the pre-screen. If NO, respondent is excluded.
2. Are you related to (CR)?
No 0 ( )
Yes 1 ( )
If YES, proceed with the pre-screen. If NO, respondent is excluded.
3. Does (CR) live with you? We consider living together as sharing cooking facilities.
No 0 ( )
Yes 1 ( )
If YES, proceed with the pre-screen. If NO, respondent is excluded.
4. How many years have you taken care of (CR)? Years
If more than six months, proceed with the screen. If less than 6 months, respondent is excluded.
For those who do not qualify based on the pre-screen:
Thank you so much for answering my questions. Based on what you have told me about your situation, it does not seem that this is the best program for you. I would like to keep your name in our files, in case there is a program in the future, which might better suit your needs. Is that okay with you?
4. Recruitment Guidelines.
1. Direct to potential subjects recruitment.
Each site will develop, in concert with other sites, mechanisms to directly contact potential subjects. This may include, but not limited to, direct mailings, PSAs, advertisements in newspapers and shopping guides.
2. Recruitment information provided by potential subjects by a community agency or organization. Note: This action is permitted by the FWA.
Each site will develop an information packet about the study for dissemination to potential subjects. The packets to be disseminated will be the same at all sites (allowing for subtle language and translation differences). These packets will include information on how the potential subject can contact the research team.
3. Local agencies will forward or provide the names of potential subjects to the research team.
Each site will utilize the same form to be provided to the community agency. Specifically, the form will document the consent of the potential subject to have their name submitted. The research team must then contact the individual, screen them for eligibility, and obtain informed consent. The consent granted by the potential subject is only for having their name submitted and does not grant any other consent. All other consent procedures must be followed. A copy of the signed permission to contact form must be placed in the potential subjects permanent folder. If the potential subject eventually enters the study, this consent sheet will be a part of that permanent record.
REACH II SUBJECT CONTACT
The person listed below has agreed to be contacted regarding possible entry into REACH II (Resources for Enhancing Alzheimer’s Caregiver’s Health II).
Patient Name:
Family member/Caregiver Name:
Address:
Street
City State Zip Code
Telephone: (H) ______/ ______/ ______
(W) ______/ ______/ ______
When/where/Best time to call:
Relationship to patient (circle one) Husband Wife Mother Father Son Daughter Sister Brother Son-in-law Daughter-in-law Friend Other
How long have you been caring for the patient?
Referral Source:______By:______
Person obtaining permission
I agree to have my name forwarded to the REACH II team to be contacted about this research study.
______Date: ______
Caregiver Signature
5. Recruitment Strategies.
(1) Brochures - With language and translations appropriate for socio-cultural context of local population.
(2) Newspaper Ads – Both daily’s and weekly “neighborhood/community” papers; targeted primarily to those who may be disconnected from formal healthcare or social service agencies.
(3) Community Flyers - Posted at local community-based resource centers/senior enters/churches/adult daycare centers.
(4) Articles in Newsletters - Alzheimer’s Association, local hospital newsletters, “senior focused” newsletters.
(5) Websites - Possibility of on-line screening.
(6) Television - Local channels and local cable access channels featuring “health spots”.
(7) Radio - Taped spots or study personnel doing a radio segment.
(8) Targeted Mailings - To Alzheimer’s Association, churches, universities, home health agencies, adult daycares and caregivers on waiting lists for services; prefaced with a personalized letter.
(9) Community Presentations - Study personnel to make presentations at local M.D. offices, home-health agencies, ministerial associations and professional organizations. Get on “talk/training” schedule for local support groups, Alzheimer’s Association and other aging-focused agencies. Offer talks/training in both English and Spanish.
(10) Health Fairs - Be a presence at any senior-focused health screenings/health fairs. Have a table with brochures, study magnets, “sticky notes”, pens/pencils and “goody bags” to put items into.
(11) Community Service - Be a presence at any local events (walks, fund-raisers, guest speakers/lectures) related to dementia or dementia patient caregiving, such as the Alzheimer’s Association and other aging-focused organizations.
(12) Churches - Target a culturally diverse population of churches to speak with; talk with ministers/priests and other on staff support personnel who might have contact with members. Ask permission to place a notice about the study in church bulletin or permission to speak to senior Sunday school classes.
(13) Faxes - Utilize weekly “fax-back” forms enabling staff members at local M.D. offices/
agencies/adult daycares to send referrals without writing out additional fax’s for each referral.
(14) Reminders/Thank you for Existing Recruitment Sites – Provide ongoing recruitment reminders and restocking of educational materials at each site. Utilize pharmaceutical detailing strategy” via small seasonal treats for office/agency staff and their patients/clients to share accompanied by a thank you note from study personnel.
6. Public Relations Material. Memphis will develop a menu of retention strategies. The workgroup discussed having a professional level brochure for presentations and flyers for the caregivers. This workgroup will develop a standard template to be used at all sites. The sites will individualize it in terms of local phone numbers and IRB standards. This workgroup will work on a PSA for the project. We will ask the Coordinating Center to do a core brochure as in REACH I.
REACH Steering Committee Meeting
The Westin Grand
2350 M Street NW
Washington, D.C. 20037
202-429-0100
Agenda
Sunday, January 6
8:30 AM Continental breakfast
8:45 Brief updates from the sites/CC/NIH
9:05 P & P Committee activities/updates on papers - Rich Schulz
9:35 Recruitment and Retention Workgroup – Bob Burns
(Workgroup leader will set the agenda for this portion of the meeting)
10:30 Break
10:45 Measurements Workgroup – Rich Schulz
(Workgroup leader will set the agenda for this portion of the meeting)
12:45 Lunch
2:00 Risk Appraisal Workgroup – Laura Gitlin
(Workgroup leader will set the agenda for this portion of the meeting)
3:30 Break
3:45 Intervention Workgroup – Laura Gitlin
(Workgroup leader will set the agenda for this portion of the meeting)
5:00 Adjourn
Monday, January 7
8:30 Continental breakfast
8:45 Intervention Workgroup discussion continued
10:00 Break
10:15 Intervention Workgroup discussion continued
12:00 Lunch
1:15 Discuss timeline and identify tasks for committees and workgroups – Sara Czaja
1:45 Develop plan for interventionist/assessor trainings – Sara Czaja
2:15 Develop outline for MOPs – Sara Czaja
2:30 Discuss Data and Safety Monitoring Board meeting – Sid Stahl/Sara Czaja
2:45 Schedule future meetings/calls/trainings – Sara Czaja
3:00 Adjourn