TY - JOUR
T1 - Behavioral interventions to prevent or delay Dementia
T2 - Protocol for a randomized comparative effectiveness study
AU - Smith, Glenn
AU - Chandler, Melanie
AU - Locke, Dona E.C.
AU - Fields, Julie
AU - Phatak, Vaishali
AU - Crook, Julia
AU - Hanna, Sherrie
AU - Lunde, Angela
AU - Morris, Miranda
AU - Graff-Radford, Michelle
AU - Hughes, Christine A.
AU - Lepore, Susan
AU - Cuc, Andrea
AU - Caselli, Maria
AU - Hurst, Duane
AU - Wethe, Jennifer
AU - Francone, Andrea
AU - Eilertsen, Jeanne
AU - Lucas, Pauline
AU - Snyder, Charlene Hoffman
AU - Kuang, Leeann
AU - Becker, Marigrace
AU - Dean, Pamela
AU - Diehl, Nancy
AU - Lofquist, Marvin
AU - Vanderhook, Shirley
AU - Myles, Diana
AU - Cochran, Denise
N1 - Funding Information:
The design and conduct of this trial was aided by patient and stakeholder advisory boards. This study was reviewed and approved by the institutional review boards of the Mayo Clinic (PR14-000885) and the University of Washington (#49235). All participants and partners have signed written consent during which they were informed of study procedures, potential risks, benefits, and their rights, including the right to withdraw consent. Study results will be published in the scientific literature, at professional conferences, to the patient and stakeholder advisory board, and to patient advocacy and community organizations. This study was supported by the Patient Centered Outcomes Research Institute (CER-1036-01897), with partial support from the University of Washington Alzheimer's Disease Research Fund and P50AG005136.
Funding Information:
The design and conduct of this trial was aided by patient and stakeholder advisory boards. This study was reviewed and approved by the institutional review boards of the Mayo Clinic (PR14-000885) and the University of Washington (#49235). All participants and partners have signed written consent during which they were informed of study procedures, potential risks, benefits, and their rights, including the right to withdraw consent. Study results will be published in the scientific literature, at professional conferences, to the patient and stakeholder advisory board, and to patient advocacy and community organizations. This study was supported by the Patient Centered Outcomes Research Institute (CER-1036-01897), with partial support from the University of Washington Alzheimer’s Disease Research Fund and P50AG005136.
Publisher Copyright:
© Glenn Smith, Melanie Chandler, Dona EC Locke, Julie Fields, Vaishali Phatak, Julia Crook, Sherrie Hanna, Angela Lunde, Miranda Morris, Michelle Graff-Radford, Christine A Hughes, Susan Lepore, Andrea Cuc, Maria Caselli, Duane Hurst, Jennifer Wethe, Andrea Francone, Jeanne Eilertsen, Pauline Lucas, Charlene Hoffman Snyder, LeeAnn Kuang, Marigrace Becker, Pamela Dean, Nancy Diehl, Marvin Lofquist, Shirley Vanderhook, Diana Myles, Denise Cochran.
PY - 2017/11
Y1 - 2017/11
N2 - Background: Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective: The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods: This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results: In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions: This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial.
AB - Background: Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective: The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods: This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results: In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions: This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial.
KW - Behavioral research
KW - Cognition disorders
KW - Dementia
KW - Secondary prevention
UR - http://www.scopus.com/inward/record.url?scp=85062251048&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062251048&partnerID=8YFLogxK
U2 - 10.2196/resprot.8103
DO - 10.2196/resprot.8103
M3 - Article
C2 - 29180344
AN - SCOPUS:85062251048
SN - 1929-0748
VL - 6
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 11
M1 - e223
ER -