Trial Outcomes & Findings for Aggression Prevention Training for Caregivers of Persons With Dementia (APT) (NCT NCT02380703)

Last Updated: 2020-12-11

Results Overview

Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances.

Recruitment status

COMPLETED

Study phase

Target enrollment

239 participants

Primary outcome timeframe

one year

Results posted on

2020-12-11

Participant Flow

2,230 persons with dementia (PWD) were contacted for telephone screening; 253 were interested and eligible for the study

239 signed written informed consent and 233 completed baseline assessments (5 were lost and 1 withdrew after signing consent); 4 were excluded at baseline due to the presence of aggression in the 3 months prior to baseline based on Cohen-Mansfield Agitation Inventory (CMAI); 1 participant withdrew prior to randomization; 228 participants were randomly assigned to a study arm (114 in each group).

Participant milestones

Participant milestones
Measure	Aggression Prevention Training (APT) APT will use active learning tools, including didactics, role-playing, and multimedia \[eg, books and digital video disc (DVDs)\] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Overall Study STARTED	114	114
Overall Study Month 3	104	109
Overall Study Month 6	102	107
Overall Study Month 12	99	100
Overall Study COMPLETED	78	78
Overall Study NOT COMPLETED	36	36

Reasons for withdrawal

Reasons for withdrawal
Measure	Aggression Prevention Training (APT) APT will use active learning tools, including didactics, role-playing, and multimedia \[eg, books and digital video disc (DVDs)\] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Overall Study Withdrawal by Subject	12	9
Overall Study Lost to Follow-up	12	12
Overall Study Caregiver death	1	0
Overall Study Person with dementia (PWD) death	7	8
Overall Study Entered Long-term Care	4	7

Baseline Characteristics

Aggression Prevention Training for Caregivers of Persons With Dementia (APT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)	Total n=228 Participants Total of all reporting groups
Age, Continuous	77.98 years STANDARD_DEVIATION 9.16 • n=5 Participants	78.31 years STANDARD_DEVIATION 8.75 • n=7 Participants	78.15 years STANDARD_DEVIATION 8.97 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	78 Participants n=5 Participants	75 Participants n=7 Participants	153 Participants n=5 Participants
Race/Ethnicity, Customized Black	24 Participants n=5 Participants	24 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Individual with Dementia-reported Overall Pain	1.38 units on a scale STANDARD_DEVIATION 1.12 • n=5 Participants	1.13 units on a scale STANDARD_DEVIATION 1.24 • n=7 Participants	1.25 units on a scale STANDARD_DEVIATION 1.18 • n=5 Participants
Caregiver-reported Overall Pain	1.44 units on a scale STANDARD_DEVIATION 1.11 • n=5 Participants	1.16 units on a scale STANDARD_DEVIATION 1.12 • n=7 Participants	1.30 units on a scale STANDARD_DEVIATION 1.12 • n=5 Participants
Geriatric Depression Scale (GDS)	11.88 units on a scale STANDARD_DEVIATION 6.25 • n=5 Participants	11.10 units on a scale STANDARD_DEVIATION 6.48 • n=7 Participants	11.49 units on a scale STANDARD_DEVIATION 6.36 • n=5 Participants
Mutuality Scale	2.93 units on a scale STANDARD_DEVIATION 0.79 • n=5 Participants	3.05 units on a scale STANDARD_DEVIATION 0.76 • n=7 Participants	2.99 units on a scale STANDARD_DEVIATION 0.78 • n=5 Participants
Zarit Burden Inventory	27.77 units on a scale STANDARD_DEVIATION 15.03 • n=5 Participants	27.00 units on a scale STANDARD_DEVIATION 13.29 • n=7 Participants	27.39 units on a scale STANDARD_DEVIATION 15.13 • n=5 Participants
Positive Aspects of Caregiving	24.18 units on a scale STANDARD_DEVIATION 9.00 • n=5 Participants	23.88 units on a scale STANDARD_DEVIATION 9.54 • n=7 Participants	24.03 units on a scale STANDARD_DEVIATION 9.25 • n=5 Participants
Revised Memory and Behavior Checklist (RMBC) - Total Frequency	8.13 units on a scale STANDARD_DEVIATION 3.79 • n=5 Participants	7.56 units on a scale STANDARD_DEVIATION 3.43 • n=7 Participants	7.85 units on a scale STANDARD_DEVIATION 3.62 • n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale	29 Participants	23 Participants

SECONDARY outcome

Timeframe: one year

The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Caregiver Burden--Zarit Burden Interview	26.12 units on a scale Standard Deviation 14.72	28.37 units on a scale Standard Deviation 16.27

SECONDARY outcome

Timeframe: one year

The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Positive Caregiving Attributes--Positive Aspects of Caregiving Scale	25.87 units on a scale Standard Deviation 8.46	25.00 units on a scale Standard Deviation 9.53

SECONDARY outcome

Timeframe: one year

Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Behavior Problems--Revised Memory and Behavior Checklist	7.86 units on a scale Standard Deviation 4.37	7.51 units on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: one year

The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)	1.19 units on a scale Standard Deviation 1.14	1.12 units on a scale Standard Deviation 1.19

SECONDARY outcome

Timeframe: one year

The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Depression--Geriatric Depression Screen (GDS), Caregiver Version	12.06 units on a scale Standard Deviation 6.98	11.43 units on a scale Standard Deviation 7.42

SECONDARY outcome

Timeframe: one year

The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Caregiver-Patient Relationship Quality--Mutuality Scale	2.91 units on a scale Standard Deviation 0.85	2.99 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: one year

The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure caregiver report of PWD pain. It consists of 4 items assessing the extent to which the the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.

Outcome measures

Outcome measures
Measure	Aggression Prevention Training (APT) n=114 Participants APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 Participants EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)	1.48 units on a scale Standard Deviation 1.07	1.20 units on a scale Standard Deviation 1.10

Adverse Events

Aggression Prevention Training (APT)

Serious events: 15 serious events

Other events: 0 other events

Deaths: 7 deaths

Enhanced Usual Primary Care (EU-PC)

Serious events: 18 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Mark Kunik, MD, MPH, Primary Investigator

Baylor College of Medicine

Phone: 713-794-8639

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Aggression Prevention Training (APT) n=114 participants at risk APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and DVDs) to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. Sessions will take place in the patient's home. Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC) n=114 participants at risk EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. Enhanced Usual Primary Care (EU-PC)
Blood and lymphatic system disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
General disorders Hospitalization	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	2.6% 3/114 • Number of events 3 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Cardiac disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Injury, poisoning and procedural complications Hospitalization	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	1.8% 2/114 • Number of events 2 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Endocrine disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Musculoskeletal and connective tissue disorders Hospitalization	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	1.8% 2/114 • Number of events 2 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Gastrointestinal disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Skin and subcutaneous tissue disorders Hospitalization	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Nervous system disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Surgical and medical procedures Hospitalization	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	2.6% 3/114 • Number of events 3 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Renal and urinary disorders Hospitalization	1.8% 2/114 • Number of events 2 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Respiratory, thoracic and mediastinal disorders Hospitalization	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
General disorders Death	1.8% 2/114 • Number of events 2 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	4.4% 5/114 • Number of events 5 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Cardiac disorders Death	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Injury, poisoning and procedural complications Death	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Nervous system disorders Death	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Renal and urinary disorders Death	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Respiratory, thoracic and mediastinal disorders Death	0.88% 1/114 • Number of events 1 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.	0.00% 0/114 • Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study. This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.